The Recall Desk

FDA (Devices) recall action 96519

Abbott Diagnostics Scarborough, Inc. recalled 3 products on 2025-04-23

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2025-04-23
Critical
0
Units
—

Why these products were recalled

The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

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

1–3 of 3

  • ModerateFDA (Devices)··2025-04-23

    ID NOW RSV 24T Respiratory Virus Assay System Higher Invalid Result Rates

    Abbott Diagnostics is recalling certain lots of the ID NOW RSV 24T respiratory virus assay system due to higher-than-expected invalid result rates compared to the product instructions.

    Product
    Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2025-04-23

    ID NOW COVID-19 2.0 Point-of-Care Test Device Recall

    Abbott is recalling certain lots of the ID NOW COVID-19 2.0 24T test device due to higher invalid result rates than stated in product instructions. The affected lots were distributed worldwide.

    Product
    Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets Component: No
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2025-04-23

    ID NOW Influenza A/B 2 24T Diagnostic Assay Invalid Result Rates

    Abbott Diagnostics is recalling certain lots of the ID NOW Influenza A/B 2 24T diagnostic assay due to higher-than-expected invalid test result rates. Affected lots were distributed worldwide.

    Product
    Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Product Description: Influenza A And Influenza B Multiplex Nucleic Acid Assay; Real Time Nucleic Acid Component: No
    Category
    Distribution
    0 states