The Recall Desk

Hazard

Test Performance Failure recalls

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

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2023-01-11

Of the 3 test performance failure 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 test performance failure 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.

1–3 of 3

  • HighFDA (Devices)·Z-0792-2023·2023-01-11

    VITEK 2 AST-GP67 Reagent Test Kit Recalled Due to Storage Condition Excursion

    Biomerieux Inc. is recalling VITEK 2 Antibiotic Susceptibility Test Kits (AST-GP67) due to storage temperature and time conditions exceeding acceptable limits, which cannot guarantee product performance.

    Product
    VITEK 2 REAGENT AST-GP67 TEST KIT 20 CARDS, CATALOG 22226
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0826-2023·2023-01-11

    Levofloxacin ETEST Clinical Test Recalled for Improper Storage Conditions

    Biomerieux Inc. is recalling 7 units of ETEST CLINICAL LEVOFLOXACIN LE 32 US S30 diagnostic test kits (Batch 1009240000) due to temperature and time storage condition violations that prevent guarantee of product performance.

    Product
    ETEST CLINICAL LEVOFLOXACIN LE 32 US S30, CATALOG 412392
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0394-2018·2018-01-31

    BD MAX Vaginal Panel Recalled for Unresolved and Indeterminate Results

    Becton Dickinson is recalling BD MAX CT/GC/TV kits due to increased rates of unresolved and indeterminate results, which may require repeat testing.

    Product
    BD MAX" CT/GC/TV. Catalog Number(s): 443824,442970,443590 (RUO).for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine from males and females.
    Category
    Medical Device
    Distribution
    0 states