The Recall Desk

Hazard

Reagent Defect 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 reagent defect 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 reagent defect 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-0814-2023·2023-01-11

    Biomerieux VITEK MS Clinical Reagent Recall Due to Temperature Excursion

    Biomerieux is recalling VITEK MS-DS clinical reagent due to temperature and time conditions that exceeded specification. Thirteen units distributed nationwide cannot guarantee product performance.

    Product
    VITEK MS CLINICAL REAGENT VITEK MS-DS, CATALOG 410893
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2350-2015·2015-08-19

    Remel Recalls PathoDx Strep Grouping Kits Due to Reagent Issues

    Remel Inc is recalling 1,859 PathoDx Strep Grouping Kits because a reagent may cause weak reactions, potentially leading to failure to identify target species.

    Product
    PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. Latex agglutination test for identification of beta-hemolytic streptococci of Lancefield Groups A, B, C, F or G from primary culture plates.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0843-2014·2014-02-05

    BioMérieux Recalls API NH Kits Due to ZYM B Reagent Defect

    BioMérieux is recalling API NH kits because a defect in the ZYM B reagent may cause false negative results in biochemical tests.

    Product
    API NH (REF 10400) API NH is a standardized system for the identification of Neisseria, Haemophilus (and related genera) and Moraxella catharrhalis (Branhamella catarrhalis), which uses miniaturized tests, as well as a specially adapted database. API NH also enables the biotyp
    Category
    Medical Device
    Distribution
    Distributed nationwide