FDA Recalls Over 500K COVID Tests Over Bacteria Risk

    FDA Recalls Over 500K COVID Tests Over Bacteria Risk
    Photo: usatoday

    The Facts

    • The US Food and Drug Administration (FDA) has recalled more than half a million COVID tests over bacterial contamination concerns.

    • 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.

    The Spin

    Establishment-critical narrative

    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

    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.

    Nerd narrative

    There's a 2% chance that there will no longer be any authorized COVID therapeutic in the US by the end of 2023, according to the Metaculus prediction community.

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