The Recall Desk

FDA (Devices) recall action 88626

Abbott Molecular, Inc. recalled 5 products on 2021-10-20

The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2021-10-20
Critical
0
Units
157,609

Why these products were recalled

There is a potential for false positive results.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–5 of 5

  • SevereFDA (Devices)··2021-10-20

    Abbott Alinity m Resp-4-Plex Respiratory Diagnostic Kit Recalled for False Positive Results

    Abbott is recalling the Alinity m Resp-4-Plex AMP Kit, an in vitro diagnostic used for respiratory pathogen testing, due to potential for false positive results affecting approximately 8,469 units distributed worldwide.

    Product
    Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2021-10-20

    Abbott SARS-CoV-2 Diagnostic Kit Recalled for Risk of False Positive Results

    Abbott Molecular is recalling 60,563 units of the Alinity m SARS-CoV-2 Amp Kit due to potential false positive test results. The affected kits were distributed worldwide from September 2021 through January 2023.

    Product
    Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2021-10-20

    Abbott Alinity m SARS-CoV-2 Amp Kit Recalled for Potential False Positive Results

    Abbott Molecular has recalled 71,314 units of the Alinity m SARS-CoV-2 Amp Kit due to potential false positive results. The kit was distributed worldwide.

    Product
    Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2021-10-20

    Abbott Respiratory Diagnostic Kit Recalled for Potential False Positive Results

    Abbott Molecular is recalling the Alinity m Resp-4-Plex AMP Kit due to potential false positive results. The recall affects 5,855 units distributed worldwide.

    Product
    Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2021-10-20

    Abbott Alinity m SARS-CoV-2 Test Kit Recalled for Potential False Positives

    Abbott Molecular recalls its Alinity m SARS-CoV-2 Amp Kit (Non-US Assay), an in vitro diagnostic test, due to potential for false positive results. Approximately 11,408 units were distributed worldwide.

    Product
    Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
    Category
    Distribution
    0 states