The Recall Desk

FDA (Devices) recall action 96500

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
5,383,584

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.

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.

1–3 of 3

  • ModerateFDA (Devices)··2025-04-23

    ID NOW COVID-19 2.0 24T Point-of-Care Device Recall

    Abbott Diagnostics is recalling certain lots of the ID NOW COVID-19 2.0 24T test device due to higher-than-expected rates of invalid test results. The affected devices were distributed nationwide.

    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 RSV 24T Respiratory Virus Panel Has Higher Invalid Test Rates

    Abbott Diagnostics is recalling specific lots of the ID NOW RSV 24T respiratory virus assay due to higher-than-expected invalid test rates. The affected lots were distributed nationwide.

    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 Influenza A/B 2 24T Nucleic Acid Assay Kits Recalled

    Abbott Diagnostics is recalling ID NOW Influenza A/B 2 24T test kits (Model 427-000) nationwide because affected lots have a higher occurrence of invalid test results than stated in the product instructions.

    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