The Recall Desk

Hazard

Diagnostic Test Failure recalls

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

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2023-01-11

Of the 1 diagnostic test 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 diagnostic test 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.

1–1 of 1

  • HighFDA (Devices)·Z-0861-2023·2023-01-11

    VITEK 2 AST-XN15 Test Kit Recalled for Temperature and Time Storage Failure

    Biomerieux Inc. recalls 58 units of the VITEK 2 AST-XN15 Test Kit after storage temperatures exceeded safe limits. Performance cannot be guaranteed. Nationwide US distribution.

    Product
    VITEK 2 REAGENT AST-XN15 TEST KIT 20 CARDS, CATALOG 423829
    Category
    Medical Device
    Distribution
    Distributed nationwide