ISSUE: The recall
described in this notice is due to the same issue that was announced in the
September 17, 2021 Letter to Health Care
Providers: Potential for False Positive Results with Abbott Molecular Inc.
Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits. Abbott Molecular
is recalling Alinity m SARS-CoV-2 AMP Kits and Alinity m Resp-4-Plex AMP Kits
because they have the potential to issue false positive results when being
used to detect SARS-CoV-2. For these tests, a “false positive” is a test
result that indicates that a person has the virus when they do not actually
have it. The false positive results may be related to the current mixing
parameters for the chemicals that are combined with patient samples to detect
the viruses. In some cases, the mixing parameters may cause a sample in one
well of the machine’s tray to overflow into another sample well. Overflow
into the wells of true negative samples that are positioned near positive
samples in the tray could produce false positive results. A false positive
result for SARS-CoV-2 could lead to:
There have been
no deaths or adverse health consequences reported from use of this test. For more
information about this recall, click on the red button "Read Recall" below. BACKGROUND: The Alinity m
SARS-CoV-2 Assay and the Alinity m Resp-4-Plex are laboratory tests used to
detect RNA of SARS-CoV-2—the virus that causes COVID-19. RECOMMENDATIONS: On
September 2, 2021, Abbott Molecular, Inc. issued an Urgent Field Safety
Notice/Field Correction Recall to all impacted customers requesting that
they:
The FDA issued a letter to clinical
laboratory staff and health care providers on September 17,
2021 recommending that health care providers and clinical laboratory
staff:
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