The Recall Desk

Hazard

Inaccurate Testing recalls

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

What the numbers show

Total
7
Critical
0
Severe
0
Most recent
2019-06-12

Of the 7 inaccurate testing 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 inaccurate testing 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.

1–7 of 7

  • ModerateFDA (Devices)·Z-1709-2019·2019-06-12

    Abbott Recalls Alinity c Cuvette Segments Due to Seating Defect

    Abbott is recalling Alinity c Cuvette Segments because individual cuvettes may seat lower than designed, potentially preventing the sample probe from making efficient contact with the cuvette bottom.

    Product
    Alinity c Cuvette Segments, List Number 04S47-01 Product Usage: The Alinity c Cuvettes are used on the Alinity c system processing module. The Alinity c processing module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and auto
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-3043-2018·2018-09-19

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products Cl- Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Cl- Slides because they do not meet maximum allowable interference claims for triglycerides in serum samples.

    Product
    VITROS Chemistry Products Cl- Slides, Product Code 844 5207 Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum and plasma using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2817-2018·2018-08-29

    bioMerieux VITEK 2 Gram Positive Test Kits Recalled for MRSA Detection Issues

    bioMerieux is recalling VITEK 2 Gram Positive Test Kits because customer reports indicated an increased rate of non-detected MRSA.

    Product
    bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General Susceptibility Card Cefotoxin and AST for Oxacillin bioMerieux VITEK 2 AST-P631 bioMerieux VITEK 2 AST-GP67 Test Kit bioMerieux VITEK 2 AST-GP71 Test Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1225-2017·2017-03-01

    Tosoh HLC-723G8 Analyzer Recalled for HbA1c Test Inaccuracy

    Tosoh Bioscience is recalling 682 HLC-723G8 analyzers because they may report inaccurate HbA1c values for patients with specific hemoglobin variants.

    Product
    Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.
    Category
    Medical Device
    Distribution
    49 states
  • LowFDA (Devices)·Z-1289-2015·2015-03-25

    Siemens N Latex IgM Reagent Recalled for Proficiency Testing Failures

    Siemens Healthcare Diagnostics is recalling specific lots of N Latex IgM reagents because they failed proficiency testing, resulting in low recovery rates for serum samples.

    Product
    N Latex IgM; In-vitro diagnostic reagent for the quantitative determination of IgM in human cerebrospinal fluid (CSF) and in paired CSF/serum samples by means of particle-enhanced immunonephelometry using the BN II and BN ProSpec Systems. The determination of IgM aids in the eval
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1449-2014·2014-04-16

    Roche Cobas c502 Analyzer Recall Due to Inactive Volume Check

    Roche Diagnostics is recalling 76 Cobas c502 clinical chemistry analyzers because the Initial Cassette Volume Check feature fails to activate when specific reagent packs are loaded.

    Product
    Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analyzer intended for the in vitro quantitative / qualitative determination of analytes in body fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1246-2014·2014-03-26

    Remel Recalls Oxoid Vancomycin Susceptibility Discs Due to Impregnation Defect

    Remel Inc is recalling Oxoid Vancomycin 30 mcg susceptibility discs because some may lack the antibiotic, potentially affecting in-vitro testing results.

    Product
    Oxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0058B. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing.
    Category
    Medical Device
    Distribution
    Distributed nationwide