More than 500,000 COVID test kits recalled because of bacteria contamination, FDA says staff KABC logo
Saturday, May 6, 2023
More than 500,000 COVID test kits recalled, FDA says
COVID test kits sold via CVS and Amazon are subject to recall because of potential bacterial contamination, the FDA says.

COVID-19 tests are supposed to let you know if you may be sick.

But some could actually make you sick.

A manufacturer is recalling more than half a million test kits that were distributed to CVS and Amazon because they may be contaminated with strains of bacteria that can cause illness, according to the FDA.

The contaminated kits may also produce false test results.

The federal agency has not received any reports of anyone actually developing illness from the kits. Still, the FDA is warning consumers to stop using and throw out any test kits that are subject to the recall. The liquid solution should not be poured down the drain.

The kits are labeled SD Biosensor, Inc. Pilot COVID-19 At-Home Tests and are distributed by Roche Diagnostics.

Lot numbers of the test kits and more information can be found from the FDA recall notice here.

About 500,000 kits were distributed to CVS and about 16,000 to Amazon.

The kits were not among those distributed for free by the federal government.

The liquid in the test kits may be contaminated with certain strains of bacteria.

During the normal testing procedure, consumers are not supposed to ingest or come into contact with the liquid in the test vial. But accidental exposure is possible, the agency notes.

"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 says.