The Recall Desk

FDA (Devices) recall action 96790

Abbott Molecular, Inc. recalled 2 products on 2025-05-21

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2025-05-21
Critical
0
Units
2,103

Why these products were recalled

There were reports of an increase in reactive negative controls and 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.

1–2 of 2

  • HighFDA (Devices)··2025-05-21

    Abbott Alinity m Resp-4-Plex AMP Kit Multiplex PCR Test Recall

    Abbott Molecular is recalling the Alinity m Resp-4-Plex AMP Kit (List Number 09N79-096) due to reports of increased reactive negative controls and false positive results in respiratory viral testing.

    Product
    Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the simultaneous qualitative detection and differentiation of RNA from SARS-CoV-2, influenza A virus (flu A), influenza B virus
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2025-05-21

    Abbott Alinity m Resp-4-Plex Amplification Kit Recall

    Abbott Molecular is recalling the Alinity m Resp-4-Plex Amplification Kit due to reports of reactive negative controls and false positive results in respiratory virus testing.

    Product
    Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the qualitative detection and differentiation of RNA from influenza A virus (flu A), influenza B virus (fl
    Category
    Distribution
    0 states