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COVID-19 At-Home Tests Sold at CVS, Amazon Recalled

FDA has significant concerns of bacterial contamination in the Pilot COVID-19 At-Home Test

The U.S. Food and Drug Administration (FDA) is warning consumers and health providers to stop using and toss out certain Pilot COVID-19 At-Home tests sold at CVS and Amazon due to “significant concerns” of bacterial contamination.

Manufacturer SD Biosensor is recalling some 500,000 tests distributed to CVS Health and 16,000 tests distributed to Amazon by Roche Diagnostics. The FDA and Roche Diagnostics are working to determine how many of the kits were sold to consumers. 

spinner image recalled Pilot COVID test
Courtesy of SD Biosensor, Inc.

None of the contaminated tests were distributed through the government’s free COVID test programs. If you received your tests via, or as part of a federal testing program, they are not subject to the recall. 

The FDA issued an advisory saying there are concerns the liquid solution provided with the kit was contaminated with bacterias such as enterococcus, enterobacter, klebsiella and serratia species and that direct contact with it could cause an infection. ​

In particular, FDA said these types of bacteria may cause illness in people with weakened immune systems or those with direct exposure to the contaminated liquid solution through standard handling, accidental spills, or misuse of the product.  What’s more, the bacterial contamination could impact the accuracy of the test. ​

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How to stay safe ​

If you have one of the contaminated kits, the FDA said to throw it in the trash and to avoid flushing the liquid solution down the drain. If the liquid in the tube contacts your skin and eyes, flush with large amounts of water. If irritation persists, the FDA said to seek medical attention. 

Be on the lookout for signs of a bacterial infection which include fever, discharge, and red eyes. If those are present or any other concerning symptoms arise, contact your doctor. If you have concerns about the result of one of these tests, talk to your healthcare provider. 

If you think you had a problem with the SD Biosensor Pilot COVID-19 At-Home Test, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form

Recalled Lots 

The FDA is advising consumers to stop using and throw out Pilot COVID-19 At-Home Test kits with the following lot numbers:

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        

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