The Recall Desk

Hazard

Inaccurate Diagnostics recalls

2 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2023-01-11

Of the 2 inaccurate diagnostics recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all inaccurate diagnostics recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–2 of 2

  • HighFDA (Devices)·Z-0857-2023·2023-01-11

    VITEK 2 AST-XN09 test kit recalled for improper storage temperature and time conditions

    Biomerieux is recalling VITEK 2 AST-XN09 test kits where performance cannot be guaranteed due to storage outside proper temperature and time parameters. Affected kits nationwide should not be used.

    Product
    VITEK 2 REAGENT AST-XN09 TEST KIT 20 CARDS, CATALOG 423425
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1456-2022·2022-08-03

    Alinity c Hemoglobin Reagent Kit Recall Due to Potentially Falsely Elevated Results

    Abbott Laboratories is recalling Alinity c Hemoglobin Reagent Kits (lots 59801UQ04 and 60763UQ09) due to a potential for falsely elevated hemoglobin A1c test results when used with ARCHITECT and Alinity c analyzers.

    Product
    REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL
    Category
    Medical Device
    Distribution
    43 states