The Recall Desk

Hazard

Reagent Degradation recalls

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

What the numbers show

Total
10
Critical
0
Severe
0
Most recent
2024-03-06

Of the 10 reagent degradation 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 degradation 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.

1–10 of 10

  • ModerateFDA (Devices)·Z-1185-2024·2024-03-06

    EMD Millipore Issues Recall of Schiff Reagent Hotchkiss-McManus for Discoloration

    EMD Millipore has recalled Schiff Reagent Hotchkiss-McManus (lots 3094 and 3096) because units appear pink instead of colorless. Laboratories should discontinue use of affected units distributed to US states and Canada.

    Product
    Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a black polypropylene cap.
    Category
    Medical Device
    Distribution
    8 states
  • 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
  • HighFDA (Devices)·Z-0837-2023·2023-01-11

    VITEK 2 Antibiotic Susceptibility Test Kits Recalled for Storage Condition Exceedance

    Biomerieux is recalling VITEK 2 REAGENT AST-GN80 test kits due to temperature and time excursions during storage or handling. Product performance cannot be guaranteed for affected units.

    Product
    VITEK 2 REAGENT AST-GN80 TEST KIT 20 CARDS, CATALOG 413437
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0793-2023·2023-01-11

    Medical Diagnostic Reagent Recalled Due to Storage Temperature Damage

    Biomerieux Inc is recalling PREVI COLOR GRAM diagnostic reagent (Catalog 29586) distributed nationwide because improper storage conditions may have degraded product performance.

    Product
    PREVI COLOR GRAM REAGENT IODINE-B (NA), CATALOG 29586
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0816-2023·2023-01-11

    Clinical Reagent Vitek MS-FA Recalled Due to Storage Condition Violations

    Biomerieux is recalling VITEK MS-FA clinical reagent due to storage condition violations that degrade product performance. The recall affects 29 units distributed nationwide.

    Product
    VITEK MS CLINICAL REAGENT VITEK MS-FA, CATALOG 411072
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2201-2021·2021-08-11

    In Vitro Diagnostic Reagent Recalled for Reagent Stability Deterioration

    Stanbio Laboratory is recalling Synchron Beta-Hydroxybutyrate diagnostic reagent due to reagent deterioration causing quality control values to fall out of expected range.

    Product
    Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2200-2021·2021-08-11

    Beta-Hydroxybutyrate Diagnostic Reagent Recalled for Stability Degradation

    Stanbio Laboratory recalled Beta-Hydroxybutyrate Reagent A due to deterioration in reagent stability. The degradation resulted in out-of-range Quality Control values that could affect diagnostic accuracy.

    Product
    Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2203-2021·2021-08-11

    In Vitro Diagnostic Reagent Recalled Due to Stability Deterioration

    Cardinal Health Beta-Hydroxybutyrate diagnostic reagent has been recalled due to stability deterioration causing out-of-range quality control values. No illnesses have been reported.

    Product
    Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro diagnostic reagent.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2267-2013·2013-10-02

    Microgenics Recalls DRI Cocaine Metabolite Assay Due to Reagent Degradation

    Microgenics Corp is recalling specific lots of DRI Cocaine Metabolite Assay because surveillance showed unexpected reagent degradation. The recall affects 1,473 units distributed across multiple US states.

    Product
    DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott Laboratories. 100 ml, IVD Mfg by: Microgenics Corporation, 46360 Fremont Blvd. Fremont, CA 94538 The DRI Cocaine Metabolite Enzyme Immunoassay is a homogeneous enzyme intended for the qualitativ
    Category
    Medical Device
    Distribution
    21 states