Authorities Warn Of Potentially Contaminated COVID-19 Tests; Thousands Of Kits Recalled

Consumers are being urged to stop using a particular at-home test for COVID-19 because a specific component may be contaminated with bacteria.

SD Biosensor on May 4 urged U.S. users of the Pilot COVID-19 At-Home Tests to stop using and to dispose of it, as per the company's recall announcement published on the U.S. Food and Drug Administration (FDA) website. This comes after "potentially harmful bacteria were found in the tube with liquid inside." This is said to be the tube inside foil pouch 2.

The liquid solution in the impacted test kits was found to be contaminated with bacteria such as Enterococcus, Enterobacter, Klebsiella and Serratia species, the FDA noted in a Safety Communication, wherein it expressed "significant" concerns regarding the potential bacterial contamination.

The issue was reportedly discovered through routine quality assurance testing, Roche Diagnostics, the company that distributed the test kits, noted.

"(A) user may inadvertently come in direct contact with the contaminated liquid during opening the tube or handling of the open tube or while performing the test," SD Biosensor said in its announcement.

"Infection from bacteria such as Enterococcus, Enterobacter, Klebsiella and Serratia species 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," the FDA said.

There is also the risk that the presence of the bacteria may affect the test's performance, the agency said. The tests may end up giving false results.

The FDA is urging users to watch out for symptoms of bacterial infection such as fever, red eyes, or discharge — those with these symptoms are advised to seek medical attention.

"Talk to your health care provider if you think you were tested with an affected Pilot COVID-19 At-Home Test, or if you have concerns about your test results," the FDA noted.

So far, there have been no reports of illnesses related to the issue.

The issuance affects certain lots of the Pilot COVID-19 At-Home Tests that were distributed to retailers in the U.S. Some 500,000 tests were reportedly distributed to CVS Health, as per the FDA, while 16,000 tests were distributed to Amazon. The agency clarified that the impacted tests weren't distributed as part of the federal testing programs.

The voluntary recall affects 44 lots of the test kits, according to Roche Diagnostics. The full list can be found on both the FDA and company statements. Customers may also locate their lot number on the kit and enter it on the tool here.

Roche Diagnostics has provided a short video on how to identify the lot number.

"SD Biosensor Inc. has conducted testing on all currently available and unexpired lots in the market," said Roche Diagnostics. "The testing indicated that contamination is isolated to the lots identified in the press release, and no additional affected lots have been identified."

SD Biosensor and the FDA are urging affected users to dispose of the entire kit in the trash without pouring the liquid down the drain.

Roche's Customer Support Center is 1-866-987-6243.

"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 agency said.