Potential False Positives Abbott Alinity m SARS-CoV-2 AMP and m Resp-4-Plex AMP Kits

U.S. Food and Drug Administration sent this bulletin at 09/17/2021 11:11 AM EDT

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FDA - Center for Devices and Radiological Health

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Potential for False Positive Results with Abbott Molecular Inc. Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits

Today, the U.S. Food and Drug Administration (FDA) issued a Letter to Health Care Providers to alert clinical laboratory staff and health care providers about the potential for false positive results with Abbott Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits.

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The Letter to Health Care Providers includes important information about Abbott Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits including,

  • Details on potential false positive results.
  • Recommendations for clinical laboratory staff and health care providers.
  • Actions the FDA is taking.
  • Instructions for reporting problems with the Alinity m SARS-CoV-2 AMP or Alinity m Resp-4-Plex AMP Kits.

Questions?

If you have questions about this Letter to Health Care Providers, email COVID19DX@fda.hhs.gov.