FDA MedWatch - Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kit by Abbott Molecular:

Class I Recall - Due to Potential False Positive SARS-CoV-2 Test Results

If your email program has trouble displaying this email, view as a webpage. MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kit by Abbott Molecular: Class I Recall - Due to Potential False Positive SARS-CoV-2 Test Results AUDIENCE: Patient, Health Professional, Risk Manager, Laboratory 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: Delayed diagnosis or treatment for the actual cause of the person's illness, which could be another life-threatening disease that is not COVID-19. Further spread of the SARS-CoV-2 virus when presumed positive people are grouped into cohorts (that is, they are housed together) based on false test results. The person receiving unnecessary COVID-19 treatment from a health care provider, such as antiviral treatment, convalescent plasma, or monoclonal antibody treatment, which can result in side effects. People not taking recommended precautionary measures against COVID-19, including vaccination. Isolation measures, including monitoring of household or other close contacts for symptoms, limiting contact with family or friends, and missing school or work. 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: Complete and return an acknowledgement letter that the notice was received. Consider all positive SARS-CoV-2 test results presumptive until the company can implement updated software specification files to correct the issue at each customer's laboratory site.  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:  Consider any positive SARS-CoV-2 result from tests using the Alinity m SARS-CoV-2 AMP and the Alinity m Resp-4-Plex AMP Kits to be presumptive.  Consider retesting positive patient specimens from tests performed in the last two weeks with an alternate authorized SARS-CoV-2 test. Consider communicating to patients who received positive results using the Alinity m SARS-CoV-2 AMP and the Alinity m Resp-4-Plex AMP Kits from June 2021 through the present to let them know that they may have had a false positive test result. Report any issues with using COVID-19 tests to the FDA. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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