Thousands of COVID Tests Have Just Been Recalled by the FDA

Updated: May 09, 2023

If you recently purchased COVID tests at either CVS or Amazon, double-check to see if it's a recalled batch before using it.

As if the testing for COVID wasn’t fraught and anxiety-ridden enough, the U.S. Food and Drug Administration (FDA) is warning consumers and healthcare providers to stop using and throw out certain lots of a popular at-home COVID test.

The FDA has recalled SD Biosensor, Inc. Pilot COVID-19 At-Home Tests, distributed by Roche Diagnostics. There are significant concerns about the liquid solution in these test kits being contaminated with bacteria. Direct contact with the contaminated liquid solution may pose safety concerns and the bacterial contamination could impact the performance of the test. About 500,000 were distributed to CVS stores and 16,000 to Amazon, according to the FDA’s advisory.

“SD Biosensor Inc., the manufacturer of the Pilot COVID-19 At-Home Test, informed Roche that this issue was identified during routine quality assurance testing. Potentially harmful bacteria were found in the liquid buffer solution,” Roche said in a statement.

Why were these COVID tests recalled?

Asian woman drops swab in a protective plastic tube after nasal swab test to check for virus at homeWhiteBalance.Oatt/Getty Images

The liquid solution provided in the affected Pilot COVID-19 At-Home Test kits has been found to be contaminated with bacteria such as Enterococcus, Enterobacter, Klebsiella and Serratia.

These organisms can cause illness in people with weakened immune systems or those directly exposed to the contaminated liquid. Additionally, the contamination can impact the performance of the tests, causing false positives or negatives.

To date, the FDA has not received reports of sickness or injury associated with the use of these at-home tests.

How can I tell if I have a recalled COVID test?

Pilot Covid 19 Test Recall Courtesy Sd Biosensor Inc FDACourtesy FDA, SD BioSensor, Inc.

The FDA is advising consumers to stop using and throw out Pilot COVID-19 At-Home Test kits with the lot numbers listed below. If you have a test kit with one of these lot numbers, do not use it. Throw out the entire test kit in the household trash. Do not pour the liquid solution down the drain.

The lot numbers are as follows:

  • 53K38N1T
  • 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