The Recall Desk

Hazard

Diagnostic Unreliability 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
1
Most recent
2023-01-11

Of the 2 diagnostic unreliability recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (50%) 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 unreliability 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

  • ModerateFDA (Devices)·Z-0863-2023·2023-01-11

    ETEST Clinical Colistin Test Product Recalled Due to Storage Conditions

    Biomerieux Inc is recalling ETEST Clinical Colistin diagnostic test products because storage conditions exceeded safe parameters, making product performance unreliable. Affected batches were distributed nationwide.

    Product
    ETEST CLINICAL COLISTIN CO 256 US B100, CATALOG 537348
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1620-2021·2021-06-09

    Leccurate SARS-CoV-2 Antigen Test Kit Recalled: Not FDA-Approved for U.S. Distribution

    The Leccurate SARS-CoV-2 Antigen Rapid Test Kit is being recalled because it was not authorized, cleared, or approved for marketing in the United States. Approximately 8.4 million units were distributed worldwide, including to U.S. states and territories.

    Product
    Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for the qualitative detection of antigen SARS-CoV-2 in clinical samples (nasal swab).
    Category
    Medical Device
    Distribution
    5 states