FDA Recalls Over 500K COVID Tests Over Bacteria Risk

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Facts

  • The US Food and Drug Administration (FDA) has recalled more than half a million COVID tests over bacterial contamination concerns.1
  • In a statement released on Thursday, the FDA warned consumers and healthcare providers to stop using and discard certain lots of Pilot COVID-19 At-Home Tests distributed by Roche Diagnostics.2
  • The FDA says it has "significant concerns" about the test kit's liquid buffer solution after finding it was contaminated with Enterococcus, Enterobacter, Klebsiella, and Serratia, warning that direct contact with it could cause infections in people with weakened immune systems.3
  • In addition, the drug regulator warns bacterial contamination could compromise the test's accuracy and may give false positive or false negative results, which may lead to a "delay in both the correct diagnosis and appropriate treatment."2
  • About 500K of the recalled tests were distributed to CVS, while about 16K were given to Amazon. None of the potentially contaminated kits were reportedly distributed through the federal government's testing programs.4
  • The recalled tests had been approved for use at home without a prescription for people aged 14 and older and for adults using the test on children as young as 2.5

Sources: 1BBC News, 2U.S. Food and Drug Administration, 3CBS, 4Dayton, and 5The Hill.

Narratives

  • Establishment-critical narrative, as provided by Wall Street Journal. The recall exposes the flaws in the FDA's approval program, which allowed defective or contaminated COVID test kits to remain on the shelves for too long after approval, potentially allowing people with false negative results to have unknowingly infected others. The agency must tighten its quality control efforts and ensure such dangerous mishaps don't arise again.
  • Pro-establishment narrative, as provided by NPR Online News. At-home COVID tests were never expected to be as sensitive, perfect, or fool-proof as the PCR tests performed in a lab or clinic for detecting infection. While the bacteria contamination is concerning, the FDA caught the issue early on and must continue to advance greater access to at-home COVID testing to best support public health needs.

Predictions