The Recall Desk

Hazard

Test Malfunction recalls

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

What the numbers show

Total
4
Critical
0
Severe
0
Most recent
2023-01-11

Of the 4 test malfunction 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 malfunction 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.

1–4 of 4

  • HighFDA (Devices)·Z-0799-2023·2023-01-11

    VIDAS Salmonella Diagnostic Test Kits Recalled Due to Storage Damage

    Biomerieux Inc. is recalling 15 units of VIDAS VIDAS Salmonella 60T diagnostic test kits (Catalog 30702) because storage conditions exceeded acceptable temperature and time parameters. The affected test kits may not perform reliably.

    Product
    VIDAS CLINICAL VIDAS SALMONELLA 60T, CATALOG 30702
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0425-2022·2022-01-05

    VIDAS diagnostic test for C. difficile recalled due to substrate defect

    bioMerieux's VIDAS Clostridium difficile diagnostic test is being recalled due to a substrate error that prevents the test from running. Users must re-test samples, potentially delaying diagnosis.

    Product
    VIDAS Clostridium Difficile Toxin A&B, CDAB,REF 30118-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0437-2022·2022-01-05

    VIDAS Lyme diagnostic test device recalled due to substrate error

    bioMerieux recalled VIDAS Lyme IgG II test devices (two lots) due to a substrate error that prevents tests from running. Users must retest patients, potentially delaying Lyme disease diagnosis.

    Product
    VIDAS Lyme IgG II (LYM), REF 417401
    Category
    Medical Device
    Distribution
    Distributed nationwide