FDA warns some COVID tests kits may be contaminated. Which one should you throw away?
If you have COVID-19 test kits at home, double check the branding because you may need to throw it away.
The U.S. Food and Drug Administration issued a warning of specific Pilot COVID-19 at-home tests made by SD Biosensor, Inc. because of potentially harmful bacteria contamination.
The over-the-counter rapid antigen test uses a nasal swab sample that can be self-collected and self-tested. The FDA has significant concerns about the liquid solution, provided in the test kit. Although it’s in a pre-filled and sealed tube, you could accidentally touch it while opening the tube or taking the test.
“Direct contact with the contaminated liquid solution may pose safety concerns and the bacterial contamination could impact the performance of the test,” the FDA said in a news release.
According to FDA officials, 500,000 tests were distributed to CVS and about 16,000 tests to Amazon. It’s not clear yet how many were actually bought.
Manufacturers found out about the issue from routine quality assurance testing.
Officials say you can check to see if you have one of the recalled Pilot tests by the lot number on the outer packaging. If your kit has one of the following lot numbers, you are encouraged to not use it:
53K38N1T1 | 53K4221T1 | 53K4292T1 |
53K38N2T1 | 53K4222T1 | 53K42A1T1 |
53K38N3T1 | 53K4223T1 | 53K42A2T1 |
53K38N4T1 | 53K4224T1 | 53K42A3T1 |
53K38N5T1 | 53K4225T1 | 53K42E1T1 |
53K38P1T1 | 53K4231T1 | 53K42G1T1 |
53K38P2T1 | 53K4232T1 | 53K42G2T1 |
53K38P3T1 | 53K4233T1 | 53K42H1T1 |
53K41T5T1 | 53K4261T1 | 53K42H2T1 |
53K41X1T1 | 53K4262T1 | 53K42L1T1 |
53K41X2T | 53K4271T1 | 53K42L2T1 |
53K41X3T1 | 53K4272T1 | 53K4361AC |
53K4211T1 | 53K4273T1 | 53K4362AC |
53K4212T1 | 53K4274T1 | 53K4392AC |
53K4213T1 | 53K4291T1 |
You can also enter the kit information online to see if yours was affected and request a replacement at-home test.
The FDA advises the public to be careful when discarding the recalled tests and do not pour the liquid from test kits down the drain. The agency warned that exposure to the liquid in the tube could potentially lead to serious illness.
Health officials also recommend reaching out to your health care provider if you think you were tested with one of the affected COVID at-home tests, or if you have concerns about your test results.
“The FDA is continuing to work with SD Biosensor Inc. to assess the company’s corrective actions to address the reason for bacterial contamination and help ensure the situation is resolved and will not return,” the release said.
The agency did clarify that none of the impacted tests were distributed through The Biden administration’s free COVID test program or other federal testing programs.
HOW TO STILL GET FREE COVID TESTS
There’s still several options for you to get free COVID tests ahead of the U.S. public health emergency order ending on May 11. The Biden administration’s federal program for free at-home test kits allows households to order a set of four tests through the United States Postal Service. North Carolina residents can also request free at-home COVID tests through the state Project Access COVID Tests program until June 30.
Once the order ends, the government may continue to distribute free tests through the United States Postal Service, states, and other community partners but that will depend on supply and resources, The Charlotte Observer previously reported.