FDA MedWatch - Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits by Abbott Molecular: Letter to Health Care Providers

Potential for False Positive Results

If your email program has trouble displaying this email, view as a webpage. MedWatch - The FDA Safety Information and Adverse Event Reporting Program Potential for False Positive Results with Abbott Molecular Inc. Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits The 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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