Hazard
31 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 31 inaccurate diagnosis recalls we have scored against our rubric, 1 (3%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (10%) are Severe.
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all inaccurate diagnosis 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.
Biomerieux Inc is recalling VITEK 2 AST-N461 test kits due to card pouch damage that may cause false resistant results, potentially leading to less effective antibiotic treatments.
Midmark is recalling Digital ECG HD+12 and HD+15 units with specific IQecg plugin software versions due to a communication anomaly that may cause incorrect ECG waveforms and inaccurate heart rate calculations.
Siemens Healthcare Diagnostics is recalling specific lots of the Emit 2000 Quinidine Assay because unacceptable precision may cause falsely high results, risking improper patient treatment.
Siemens is recalling 20 units of the Syva EMIT 2000 Quinidine Assay due to precision issues that may cause inaccurate test results.
BioFire Diagnostics, LLC is recalling the Spotfire Respiratory/Sore Throat Panel due to false negative test results and control failures that may not accurately detect infections.
Siemens IMMULITE 2000 allergen testing kits may produce falsely elevated results for mold allergen-specific IgE, potentially leading to incorrect mold allergy diagnoses.
Confirm Biosciences is recalling Healgen COVID-19 Rapid Test Cassettes because they were distributed to non-certified labs and not validated for fingerstick use.
Ameditech Inc is recalling 537,120 units of First Check 4 Panel Drug Cups because they may fail to consistently detect all compounds at labeled levels.
Ameditech Inc is recalling 23,000 MicroScreen immunoassay units because they failed to consistently detect compounds at labeled levels.
Ameditech Inc is recalling First Check 1 Panel Drug Cup (THC) units because immunoassay enzymes failed performance tests, preventing consistent detection of compounds.
Abbott is recalling 83 kits of ARCHITECT HAVAB-G Calibrator, lot 08219BE00, because increased RLU values may cause false non-reactive patient results.
Siemens Medical Solutions is recalling 564 ACUSON SC2000 ultrasound systems because a specific application may underestimate the Effective Regurgitant Orifice Area (EROA) compared to other transducers.
Magellan Diagnostics is recalling LeadCare Ultra Blood Analyzers because they may generate falsely low lead concentrations when used with specific Becton Dickinson collection tubes.
Carestream Health is recalling Touch Prime and Touch Prime XE ultrasound units because a software issue may cause anatomy volume measurements to be overestimated.
Ameditech is recalling DrugCheck Waived 12 Panel Cup tests because they have shown reduced reactivity.
Ameditech is recalling Micro Screen 6 Panel Cup drug abuse tests because they have shown reduced reactivity.
Volcano Corporation is recalling s5/s5i/CORE Intravascular Ultrasound Systems due to a software issue that may cause inaccurate FFR/iFR values.
Volcano Corporation is recalling s5, s5i, and CORE Intravascular Ultrasound Systems due to a software issue that may calculate inaccurate FFR/iFR values.
Volcano Corporation is recalling Volcano s5/s5i/CORE Intravascular Ultrasound Systems due to a software issue that may cause inaccurate FFR/iFR values.
Volcano Corporation is recalling specific software versions for its s5 and CORE Intravascular Ultrasound Systems because they may calculate inaccurate FFR/iFR values under certain circumstances.
Abbott Point of Care is recalling i-STAT G3+ Cartridges (Lot N13183) because they may produce incorrectly elevated PCO2 and depressed pH results.
Alere San Diego, Inc. is recalling specific lots of the Alere Triage TOX Drug Screen because they produce false negative results for PCP more often than stated in the package insert.
Radiometer America is recalling D788 pCO2 membranes because they may cause biased measurement results for patients and quality control.
Siemens is recalling HbA1c Flex reagent cartridges due to positive bias and frequent out-of-range flags, which may affect diabetes monitoring.
Roche Molecular Systems is recalling specific lots of cobas 4800 HPV test kits because a formulation error was identified during the manufacture of the Master Mix reagent.