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FDA Clarifies Software Link In Abbott COVID-19 Lab Test Recall

 
• By Elizabeth Orr

The recall is related to the software’s mixing parameters, which may cause false positives if test samples contaminate each other.

The word ERROR and binary code on a digital screen.
• Source: Alamy

Abbott Molecular Inc.’s ongoing recall of some COVID-19 lab tests that may display false-positive results is related to a software issue and doesn’t involve any flaws in the physical test components, the US Food and Drug Administration has clarified.

The agency initially announced the recall of the Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kits in September, then released its designation as high-risk class I on...

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Makary Proposes Combined Adverse Event Reporting Systems In Megyn Kelly Interview

 
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More from Policy & Regulation

FDA Rebukes Four Companies, Including One Overseas, For Procedural Failures

 
• By Brian Bossetta

The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.

EU Finalizes Framework For Joint Clinical Assessments Of High-Risk Devices

 
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Get Ready For International Harmonization Before Approaching QMSR Deadline, Says Regulatory Expert

 
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