Top Class False-positive results could also lead to further spread of the SARS-CoV-2 virus when presumed positive people are grouped into cohorts (that is, they are housed together). Verywell Health's content is for informational and educational purposes only. However, you should be on alert. How do I report a problem with an at-home OTC COVID-19 diagnostic test? What should I do if I have a counterfeit at-home OTC COVID-19 diagnostic test? authorized a new at-home antigen test, ACON Laboratories' Flowflex. Recall Number: Z-0421-2022: Recall Event ID: 89028: Product Classification: Coronavirus antigen detection test system. The only authorized Flowflex distributors are listed on our website: This is not a recall, as these counterfeits were not manufactured, imported, or distributed by ACON Laboratories. This correction should be carried out to the consumer/user level in U.S. Refer to the table for the new expiration date using the lot . Approximately 200,100 Flowflex SARS-COV-2 Antigen Rapid Tests (Self-Testing) have been recalled by the Food and Drug Administration (FDA) as the tests were never granted approval by the agency. Variations in trade, product, and company names affect search results. Contact the distributor or store where you purchased the test to inform them that you received a counterfeit test, and also inform the manufacturer of the authorized test. The test, which comes in a blue box, is not to be confused with the FDA-approved Flowflex COVID-19 Antigen Home Test, which comes in a white box. All rights reserved. If the test you have has the same name as one listed on this page, follow the instructions below to check for signs that it is counterfeit or to confirm that it is the real, FDA-authorized product. Note: If you need help accessing information in different file formats, see 2023 ACON Laboratories, Inc. | All Rights Reserved. Once you've got enough legitimate at-home COVID-19 tests for your household, think carefully about using themand try not to stockpile more than you really need. These counterfeit tests have not been reviewed or authorized by FDA, and the FDA has no current evidence of their performance. - Product Code QKP: Product: Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked: Code Information: Lots: COV1080201, COV1105014: Recalling Firm/ Manufacturer: Acon Biotech (Hangzhou) Co., Ltd. Recall Number: Z-0945-2022: Recall Event ID: 89755: Product Classification: Coronavirus antigen detection test system. - If you have used these devices to determine your SARS-CoV-2 infection status, it is possible that your test result is incorrect. The recall caught the attention of public health officials in at least one New York county, who issued a notice to residents on Friday. In Philadelphia, a fake testing site claimed that it was working for the Federal Emergency Management Agency, which was not true. SAN DIEGO, CA, January 9, 2022 ACON Laboratories, Inc. (ACON Laboratories), the legal manufacturer of the Flowflex COVID-19 Antigen Home Test (FDA Emergency Use Authorization EUA210494), has identified the U.S. distribution of unauthorized, adulterated and misbranded counterfeit product having the trade name Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing). ACON Laboratories is not importing the Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) into the U.S. as it is only authorized for sale in Europe and other markets, under the CE mark. and salmonella, a bacterium where in the event of infection can cause diarrhea, fever, and stomach cramps. Now that COVID-19 tests are a hot commodity, people are trying to make sure that they have enough on hand. In addition to the recalled tests, fake test kits have also started to circulate. The packaging and components of the fraudulent tests very closely resemble real, FDA-authorized Flowflex tests. Before sharing sensitive information, make sure you're on a federal government site. As of this week, the manufacturer said it has not received any reports of "adverse events" related to either test and has issued the recall "out of an abundance of caution.". The Flowflex COVID-19 Antigen Home Test has an expiration date that is extended by 9 months. (CMR) A common rapid at-home COVID test was recalled by the FDA last month over concerns the antigen test hasn't received proper U.S. authorization. False-positive antigen test results may lead to a delay in both the correct diagnosis and the initiation of an appropriate treatment for the actual cause of a persons illness, which could be another life-threatening disease that is not COVID-19. COVID-19 Antigen tests in Europe without the CE mark can pose significant risk since they may lead to inaccurate test results, including false negative or false positive test results. Your notification to your customers may be enhanced by including a copy of this correction notification letter. Do not notify me when my concern is resolved. The federal government will start mailing COVID-19 test kits to Americans starting in late January. Unreliable test results could mislead people who are sick with COVID-19 and contribute to the continued spread of the virus. The FDA is urging consumers to inspect their stock of COVID-19 tests and discard any of the recalled products in their possession. All Rights Reserved. If you're not sure if a test has the FDA's authorization, check the website. Recalls, Market Withdrawals, & Safety Alerts, Recalls, Market Withdrawals and Safety Alerts, Recalls, Market Withdrawals, & Safety Alerts, Archive for Recalls, Market Withdrawals & Safety Alerts, ACON Laboratories Issues a Recall of Non-EUA Authorized Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) Tests From the U.S. Market, Recent Recalled Product Photos on FDA's Flickr Photostream. False-positive results could also lead to further spread of the SARS-CoV-2 virus when presumed positive people are grouped into cohorts (that is, they are housed together). Because of this, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. Fda safety report id # (b)(4). and best wishes in your recovery. Instructions for Downloading Viewers and Players. Fraudulent test sites have also cropped up in some cities. It is recommended to stop use and dispose of affected devices in the U.S. market: https://www.aconlabs.com/news/. Flowflex Ball Valves are a quick way of isolating flow in a system. Refer to the table for the new expiration date using the lot number printed on the test kit box. expected to be mailed out. These two products have been authorized by the U.S. FDA and registered under CE Mark authorities separately under different product registration requirements, and therefore: - This recall shall have no impact on the distribution and use of the CE marked Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) in Europe and other markets outside of the U.S. - This recall shall have no impact on the distribution and use of the FDA authorized Flowflex COVID-19 Antigen Home Test in the United States. An official website of the United States government, : Certain types of report information are protected from public disclosure under the Freedom of Information Act (FOIA). Update: Flowflex tests extend date. This recall shall have no impact on the distribution and use of the CE marked Flow, This recall shall have no impact on the distribution and use of the FDA authorized Flow. The product has not been approved, cleared, or authorized for use in the U.S. To help differentiate the recalled product from the FDA authorized product, please find the table below, highlighting differences in the product kit box labeling. Can be used on children as young as 2 years old. Apr 15, 2022 ACON Laboratories, Inc., of San Diego, California, has become aware that counterfeit versions of its FDA-authorized Flow flex COVID-19 Antigen Home Tests are being illegally imported and sold in the United States through unauthorized distributors and resellers who have no connection to ACON Laboratories. The Food and Drug Administration (FDA) recently recalled about 200,000 test kits that were not authorized. Giving out this sensitive information, which should not be required for a real COVID test, opens people up to identity theft. ACON is working closely with the FDA and other law enforcement agencies to ensure that only the FDA authorized "Flowflex COVID-19 Antigen Home Test" is distributed in the U.S. Any distribution of the "Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)" should be reported immediately to ACON Laboratories and the FDA at the numbers provided below. Being mindful about where you purchase a test matters, too. The recall of the test, which the government estimates has 200,000 in U.S. circulation, may confuse consumers between two Flowflex branded antigen tests. Flowflex Float valves provide a mechanism to fill water tanks, such as toilet cisterns. Email us at support@safelyhq.com if you have questions. Counterfeit COVID-19 tests are tests that are not authorized, cleared, or approved by the FDA for distribution or use in the United States, but are made to look like authorized tests so the users. IMPORTANT - Your report is queuedIt may take up to 12 hours to process your report. These results have been shared with the FDA. Easy-to-use nasal swab test Can be used to test children as young as 2 years old For use with and without COVID-19 symptoms Results in 15 minutes No need to send off to a lab to obtain results Customer Support Telephone: 1 (800) 838-9502Customer Support Email: flowflex_support@aconlabs.comConsumer Website: flowflexcovid.com, More Recalls, Market The government of Orange County postponed the previously scheduled distribution of the recalled tests planned for Monroe, and announced that anyone who received the test at Wallkill and New Windsor events can exchange their antigen test for a new one at a later event. These counterfeit tests have not been reviewed or authorized by FDA, but current evidence suggests the counterfeit tests are not performing as well as the authorized tests. As described in a previous public notice, these counterfeit tests may be identified by several differences, including the absence of a Lot Number / Expiration Date / 2D-datamatrix label on the kit boxes, and a test cassette pouch labeled as "SARS-CoV-2 ANTIGEN RAPID TEST (SELF-TESTING)" with a Lot Number of COV2015122. According to Amler, who is also the former Chief Medical Officer at the Centers for Disease Control and Preventions Agency for Toxic Substances and Disease Registry, "many test descriptions indicate FDA emergency use authorization (EUA), but some may not show it.". Brand name: Flowflex Product recalled: SARS-CoV-2 Antigen Rapid Test (Self-Testing) Reason of the recall: Unauthorized U.S. distribution-counterfeited product FDA Recall date: March 11, 2022 Check the full recall details on fda.gov Source: FDA, We recommend photos and videos to help explain your report, Enter below to get emailed a copy of your report, or sms a link to your report. The package should also include instructions for using the test. Coronavirus (COVID-19) and Medical Devices, Recalls, Market Withdrawals and Safety Alerts, Coronavirus (COVID-19) and Medical Devices, Counterfeit At-Home OTC COVID-19 Diagnostic Tests, At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions, Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers, Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators for COVID-19, Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA), Contacts for Medical Devices Related to COVID-19. They detect viral proteins called antigens that show if you have a current COVID-19 infection. Actions does not process claims and we cannot advise you on the While most are valid and run by health organizations, fraudulent sites have appeared, too. Get alerts and updates for your case! ACCURATE. Coronavirus antigen detection test system. The FDA has extended the shelf-life the Flowflex COVID-19 antigen kits distributed by USC Student Health. Please review our Affiliate Link Disclosure for more information. Do not use counterfeit iHealth COVID-19 Antigen Rapid Test Kits. Before the Delta variant showed up, there were plenty of rapid tests available, but the need for them tailed off as COVID vaccines arrived. Establishing a cause-and-effect relationship is especially difficult if circumstances surrounding the event have not been verified or if the device in question has not been directly evaluated. Easy and Affordable Highly Accurate Nasal Swab Test Quick Results in 15 minutes In some cases, the paper Instructions for Use included in the box with the counterfeit test may have a minor difference in the images showing examples of positive test results. These counterfeit tests have not been reviewed or authorized by FDA, but their packaging and components very closely resemble authentic FDA-authorized Flowflex tests. . The reliability of negative tests is not affected. Recently, the FDA recalled 200,000 boxes of the FlowflexSARS-CoV-2 Antigen Rapid Test (Self-Testing), which is made by ACON Laboratories. COVID-19 Antigen tests in Europe without the CE mark can pose significant risk since they may lead to inaccurate test results, including false negative or false positive test results. A false-positive antigen test result means that the test says the person has COVID-19 but they actually do not have COVID-19. Lot Number Range: New Expiration Date: COV1100041 to . The authorization "is expected to double rapid at-home testing capacity in the U.S. over the next several. On November 4, 2021, Migo Trading issued URGENT MEDICAL DEVICE RECALL notices and response forms dated November 1, 2021 to customers via email. ACON is working closely with the FDA and other law enforcement agencies to ensure that only the FDA authorized Flowflex COVID-19 Antigen Home Test is distributed in the U.S. Any distribution of the Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) should be reported immediately to ACON Laboratories and the FDA at the numbers provided below. Search Alerts/Recalls : New Search | Submit an Adverse Event Report: Brand Name : FLOWFLEX COVID 19 ANTIGEN TEST: Type of Device: CORONAVIRUS ANTIGEN . The Food and Drug Administration issued a recall late last month for "Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)," a product sold at an unknown number of pharmacies and distributed by . The FDA is providing the information on this page to help consumers identify counterfeit test kits that imitate the FDA-authorized Flowflex COVID-19 Antigen Home Tests (in white boxes), but are not authorized, cleared, or approved by the FDA for distribution or use in the United States. Non-EUA authorized, CE marked, SARS-CoV-2 antigen rapid test kits are being recalled from the U.S. market because use may lead to inaccurate test results, including false negative or false positive test results. Here are some resources to make sure that tests you get are legit: The information in this article is current as of the date listed, which means newer information may be available when you read this. If you have received the Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) with the blue box in the U.S. market, you should stop using this product and dispose of it. U.S. health officials announced a recall earlier this month of more than 500,000 COVID-19 at-home tests after the liquid used in the kits was found to be contaminated with bacteria.. SD Biosensor Inc., the maker of Pilot COVID-19 At-Home tests, issued the voluntary recall on May 4 and urged consumers and health care providers to check lot numbers and throw away any contaminated tests. The First Test for COVID and Flu Is Here. The fraudulent tests discussed on this page are not the same as the previously reported issue with the unauthorized ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing). your claim status, claim form or questions about when payments are that reports on class action lawsuits, class action settlements, The product has not been approved, cleared, or authorized for use in the U.S. To help differentiate the recalled product from the FDA authorized product, please find the table below, highlighting differences in the product kit box labeling. Check out our list of Class Action Lawsuits and Class Action Settlements you may qualify to join! Your contact information is not shown on the website. International Distribution to countries of: Hungary and China. Confirming whether a device actually caused a specific event can be difficult based solely on information provided in a given report. To date, ACON Laboratories has not received any reports of adverse events related to the products addressed in this public press release and is issuing this recall out of an abundance of caution. Tell us what brand of COVID-19 tests you use at your home in the comments section below! Utah, Virginia, Vermont, Washington and Puerto Rico. Actions to limit exposure based on false-negative results might not be taken, such as isolating people, limiting contact with family and friends, and limiting ability to work. To date, ACON Laboratories has not received any reports of adverse events related to the products addressed in this public press release and is issuing this recall out of an abundance of caution. For example, fake sites in Chicago were asking for people's credit card information or Social Security numbers. It's a super scam. Does Health Insurance Cover At-Home COVID Tests? Distribution Dates: April 13, 2021 to August 26, 2021 Devices Recalled in the United States: 2,212,335 Date Initiated by Firm: October 1, 2021 Device Use The Ellume COVID-19 Home Test is an antigen. document.getElementById( "ak_js_5" ).setAttribute( "value", ( new Date() ).getTime() ); @2023 Top Class Actions. The Food and Drug Administration issued a recall for popular Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) at the end of December stating that the "devices are determined to be inconsistent with the firm's Emergency Use Authorization . If you have received the Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) with the blue box in the U.S. market, you should stop using this product and dispose of it. drug injury lawsuits and product liability lawsuits. COV1080232 - Expiration date: 05/13/2023; The "Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)" cannot be legally imported, distributed, or used in the U.S. market as it has not been approved, cleared, or authorized by the FDA. This press release serves as public announcement that this CE marked product is being recalled from the U.S. market. COVID-19 Antigen Home Test, when stored at 36-86F (2-30C). What products has FDA identified as counterfeit at-home OTC COVID-19 diagnostic tests? What is the FDA doing about counterfeit at-home OTC COVID-19 diagnostic tests? (WWTI) The Food and Drug Administration has issued a recall on the "Flowflex SARS-CoV-2 Antigen Rapid Test." According to the FDA, this test was first recalled in early January by ACON. The product has not been approved, cleared, or authorized for use in the U.S. To help differentiate the recalled product from the FDA authorized product, please find the table below, highlighting differences in the product kit box labeling. Note that the CE marked product has ACON Biotech (Hangzhou) Co., Ltd. as the manufacturer in place of ACON Laboratories, Inc.. Do You Need to Retest After a Positive COVID-19 Result? Do not use counterfeit Flowflex COVID-19 Test Kits. This product was distributed to distributors in Delaware, Rhode Island, Texas, and California, and reached consumers through retail stores and online.
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