Class Actions & Claims

SD Biosensor announces Pilot COVID-19 At-Home Tests recall due to bacterial contamination

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COVID tests recall overview: 

  • Who: SD Biosensor recalled its Pilot COVID-19 At-Home Tests. 
  • Why: The company found potentially harmful bacteria inside the tube containing liquid.
  • Where: The SD Biosensor recall is active in the United States.

SD Biosensor recalled its Pilot COVID-19 At-Home Tests after finding potentially harmful bacteria in them. 

The U.S. Food & Drug Administration (FDA) website published the recall May 5. It applies to multiple lots of the Pilot COVID-19 At-Home Test, an over-the-counter rapid antigen test that uses a nasal swab sample.

According to the COVID tests recall, SD Biosensor found potentially harmful bacteria in the tube containing liquid (in the second pouch of the kits).

“The affected tests can be identified by the lot number on the outer packaging and should be appropriately discarded,” the recall states. “Dispose of the entire test kit in the household trash. Do not pour the liquid down the drain.”

To date, no illnesses have been reported, the company says. SD Biosensor is not currently facing legal action over the recall, but Top Class Actions follows recalls closely as they sometimes end in class action lawsuits.

Tests distributed across US, COVID tests recall says

Roche Diagnostics distributed the affected test kits to distributors and retailers in the United States.

Individuals performing the self-test may run the risk of direct contact with the contaminated liquid in the tube. Direct exposure to the liquid in the tube through misuse or spillage could potentially lead to serious illness, SD Biosensor says. If the liquid in the tube contacts your skin and eyes, flush with large amounts of water, and, if irritation persists, seek medical attention.

In related news, the FDA issued a number of medical device recalls last year, including for COVID-19 test kits, ventilators and delivery catheters. 

Are you affected by the COVID tests recall? Let us know in the comments! 



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