9:36 PM / Saturday September 23, 2023

15 Sep 2023

Health Department issues recall for at-home COVID-19 tests

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September 15, 2023 Category: Local Posted by:

PHILADELPHIA—The Philadelphia Department of Public Health is notifying residents who received what they believe to be Flowflex COVID-19 Antigen Home Tests to check the lot numbers on those tests. If the lot number shown is COV2110012, they should throw the tests away and pick up replacement tests from any of the five Health Department Resource Hubs.

During a routine shelf-life extension program check, Health Department staff recorded an unknown lot number on Flowflex COVID-19 Antigen Home Tests received from a long-time distributor. Upon investigation, it was found that this lot number was not listed on the U.S. FDA’s shelf-life extension website. A sample test kit was sent to ACON Laboratories, the manufacturer, who confirmed that tests with that lot number were not authentic. As soon as that confirmation was made, the Health Department removed those tests from distribution status and is working to notify community organizations and other partners that may have received them. Images of the valid and invalid testing kits are below.

A total of 105,000 test kits received by the Health Department were found to be invalid. Some additional number of test kits were sent directly to community partner organizations by the vendor. Approximately 4,000 invalid test kits were distributed through the Health Department. 

An additional unknown number was distributed by partners who received these test kits directly from the distributor. Anyone who received what they believe to be a Flowflex testing kit from the Health Department or as part of a Health Department program should check the lot number and discard it if they find the invalid number.

“One of the most important things that Philadelphians can do to prepare their families for the fall and winter COVID season is to have at-home testing kits on-hand,” said Health Commissioner Dr. Cheryl Bettigole. “It’s important to have faith in those tests, so we want to make sure that every test out there is valid and correct. That’s why working to make sure that our community partners and the public are aware of this recall: because not only should you have tests at home in case someone is feeling under the weather, but you should have faith that those tests can correctly diagnose you. If you don’t have any COVID tests at home for the next time you or a family member aren’t feeling well, you can pick up free tests at any of our five resource hubs.”

The Health Department is conducting a full inventory check of all COVID-19 tests in stock to ensure that they are valid; and developing new procedures to confirm lot numbers and expiration date prior to shipment from our vendor. Additionally, the Health Department is working with the vendor to replace all invalid tests. 

The Health Department has also notified other health departments across the country to be aware of this problem and to check their stores. Between July 1, 2022 and June 30, 2023, the Health Department distributed more than 285,000 COVID-19 tests at mobile testing units, resource hubs, and through the test kit distribution program, which provides tests to community-based organizations, event organizers, and venues.

Residents who are interested in receiving free COVID-19 tests or getting PCR tested should visit the Health Department’s Find a COVID-19 Test website.

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