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FDA Recalls Over 500,000 Covid Tests Due to Bacterial Contamination

The U.S. Food and Drug Administration (FDA) has issued a warning, urging the disposal of over half a million Covid-19 tests due to “significant concerns” over bacterial contamination. The contaminated tests have the potential to cause infections, particularly in people with weakened immune systems.

The Recall Announcement

SD Biosensor, Inc., the manufacturer of the Pilot COVID-19 At-Home Tests, announced the recall of more than 40 batches of their product due to the presence of possibly harmful bacteria in the liquid solution. The FDA has identified the contaminated bacteria as enterococcus, enterobacter, klebsiella, and Serratia species. These bacteria have the potential to cause severe illness, especially in individuals with weakened immune systems.

Recalled Tests Delivered to CVS Health and Amazon

The FDA revealed that around 500,000 of the recalled tests were delivered to CVS Health and roughly 16,000 were sent to Amazon. The affected tests can be identified by the lot number on the outer packaging and should be disposed of immediately. Pouring the liquid down any household drain is not recommended.

False Results and Serious Illness

The recall announcement also noted that the contaminated kits may produce false test results. Direct exposure to the liquid inside the sealed tube, through misuse or spillage, could potentially lead to serious illness. The FDA has cautioned that none of the recalled lots were distributed through federal testing programs or

How to Identify the Recalled Tests

The lot number on the outer packaging of the Pilot COVID-19 At-Home Test kit can be used to identify whether the kit is part of the recall. The FDA has urged individuals with the recalled tests to dispose of them immediately, preferably in sealed bags. The liquid in the test tube is not safe for pouring down household drains and should be disposed of with caution.


The recall of over half a million Covid-19 tests is a significant public health concern. Individuals who have been exposed to contaminated tests are urged to monitor their health closely and seek medical attention if they experience any adverse symptoms. The FDA continues to monitor the situation closely to ensure that all contaminated tests are removed from the market and disposed of safely.

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