Hazard
97 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 97 diagnostic inaccuracy recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (5%) are Severe.
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all diagnostic inaccuracy 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.
Bio-Rad is recalling BioPlex 2200 Anti-CCP reagent kits due to reduced specificity that may cause false positive results. Four customer complaints documented discrepant results during validation testing.
Randox Laboratories is recalling CRP Immunoturbidimetric reagent Batch 588434 because the antibody component shows a positive bias on patient samples, producing elevated test results compared to previous batches. Quality control samples remain within acceptable range.
Siemens Healthcare is recalling 1,865 Atellica IM Folate 700 diagnostic kits nationwide and internationally. The kits may produce inaccurate folate test results when whole blood calibration is used instead of serum calibration.
The biokitHSV-2 Rapid Test has been recalled due to the potential for false positive results. The recall affects approximately 2,393 test kits distributed across NY, CA, IN, NC, and VA.
Siemens is recalling 7,543 kits of IMMULITE 2000 Thyroglobulin diagnostic tests due to potential accuracy and precision issues affecting diagnostic reliability.
Biomerieux Inc is recalling ETEST antibiotic susceptibility test strips due to storage temperature and time excursions that may affect test performance. No illnesses or injuries have been reported.
Biomerieux Inc is recalling PREVI COLOR GRAM diagnostic reagent (Catalog 29586) distributed nationwide because improper storage conditions may have degraded product performance.
Ortho-Clinical Diagnostics is recalling VITROS Intact PTH Reagent Packs due to negatively biased measurement results (average -12% shift). The affected reagent lots were distributed worldwide and may produce inaccurate patient test results.
Sensititre diagnostic plates may give false antibiotic susceptibility results for certain bacteria species, potentially affecting treatment decisions. The FDA issued a Class I recall for approximately 1,917 units distributed nationwide.
Thermo Scientific Sensititre CMC7AFLF Gram Negative diagnostic tests may produce false susceptible results for certain bacteria, potentially leading to ineffective antibiotic treatment decisions. The FDA has classified this as a Class I recall.
GS Biomark LLC distributed approximately 639,200 CoViPoint COVID test kits without FDA approval, clearance, or authorization across multiple US states.
Bio-Rad Laboratories is recalling 180 CMV IgM EIA diagnostic test kits due to unusually high rates of false positive results. The recall affects test kits distributed in 14 U.S. states.
Abbott is recalling 883 Alinity m diagnostic systems due to software defects affecting sample identification, system operation, and test calibration. The issues affect all serial numbers running software version 1.6.5.
Siemens N Antiserum to Human IgG reagent batches are not meeting performance standards for high-dose immunoassay testing. The issue affects 10,201 packs distributed nationwide and may result in inaccurate diagnostic test results.
Associates of Cape Cod is recalling Fungitell STAT IVD Assay kits due to incorrect printed information on clamshells regarding reconstitution and pretreatment volumes. Users should verify procedures against official documentation before use.
Abbott Molecular is recalling the Alinity m System due to incorrect optical calibration. The affected unit (Serial Number 00654) was distributed to Italy.
North American Diagnostics is recalling SARS-CoV-2 rapid antigen test kits that were distributed without FDA approval or clearance. Approximately 122,366 units were sold to consumers across multiple US states and internationally.
LumiraDx recalled SARS-CoV-2 Antibody Test Strips after discovering modifications were made outside the FDA-approved Emergency Use Authorization scope. The recall affects 635 units in 13 states.
Luminex Corporation is recalling the Verigene CDF Nucleic Acid Test due to potential false negative results caused by the swab's hydrophobic characteristics, which could result in missed positive diagnoses.
Specific lots of VITROS FSH, LH, and Prolactin reagent kits may produce falsely high or delayed test results at low measurement levels. Affected lots distributed worldwide; labs should discontinue use and contact the manufacturer.
USA Medical, LLC distributed 2055 COVID-19 antigen test kits nationwide. The tests did not receive FDA Emergency Use Authorization nor were they cleared or approved for commercial distribution.
ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test kits are being recalled due to insufficient clinical performance data. The FDA determined test results may not be accurate, with potential false positives or false negatives.
Qiagen Sciences' KRAS mutation testing kit can produce false positive or false negative results due to testing flags or warnings. 435 kits distributed across 16 U.S. states are affected.
Siemens Healthcare Diagnostics is recalling Atellica CH Fructosamine reagent (lots 211359, 211451) due to potential reagent carryover that could affect diagnostic test accuracy.
Abbott Laboratories is recalling 306 units of Alinity s System software version 2.8.0 due to a software error causing insufficient wash buffer volume, which could affect diagnostic test accuracy.