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. 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. |
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