Hazard
63 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 63 inaccurate test results recalls we have scored against our rubric, 1 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (2%) are Severe.
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all inaccurate test results 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.
Beckman Coulter is recalling Access Total T4 Calibrator lots because they produce falsely low patient results on DxI 600/800 instruments, potentially leading to unnecessary testing, delayed treatment for thyroid disorders, and incorrect dosing in pregnant patients.
Beckman Coulter is recalling the Access Testosterone assay (Catalog Number 33560) due to inadequate maintenance on manufacturing equipment that caused cross-contamination in testosterone reagent packs, which could result in inaccurate patient test results.
Beckman Coulter is recalling sample probes with defective tips used in clinical chemistry analyzers. The defective probes may dispense lower sample concentrations, potentially leading to false low test results and delayed diagnosis.
Beckman Coulter Mishima is recalling sample probes due to a manufacturing defect where rounded and chamfered corners prevent proper air layer formation, causing sample dilution and inaccurate test results.
Beckman Coulter is recalling Apo B Reagent due to an erroneous value in the calibration sheet that could generate incorrect patient test results with positive bias up to 42%.
Siemens Healthcare Diagnostics is recalling epoc BGEM BUN Test Cards (25 pk) due to discrepant high pH results when samples are introduced with higher injection volumes on affected sensor configurations.
Beckman Coulter's Access Erythropoietin (EPO) reagent lot 439363 produces falsely decreased test results with patient samples. Affected results may lead to improper diagnosis or unnecessary repeat testing.
Beckman Coulter is recalling Access PTH assay reagent packs from lot 339071 due to under- or over-filling in well 0, which could cause sealing issues, contamination, and inaccurate test results.
Siemens Atellica CH β2-Microglobulin reagent may produce falsely depressed test results for samples between 18-30 mg/L, potentially leading to missed or delayed kidney disease diagnoses. No illnesses have been reported.
Qualigen Inc is recalling the FastPack TSH Calibrator Kit due to an incorrect barcode linked to incorrect information. The barcode defect may allow successful system calibration, but TSH test results obtained could be higher than expected.
Siemens Healthcare Diagnostics is recalling 9783 kits of the Atellica IM aTPO Assay diagnostic test due to positive bias in patient results below the 60 U/mL cut-off level, which may produce inaccurate test results.
Siemens Healthcare's ADVIA Chemistry Microalbumin diagnostic test may produce falsely low results. Eight lots do not meet High-Dose Hook Effect and Prozone Effect specifications, potentially affecting microalbumin detection accuracy.
Radiometer Medical ABL800 FLEX blood gas analyzers (models 393-800, 393-801) may report inaccurate pH results due to bacterial growth in calibration solution bottles. Approximately 27,127 units distributed worldwide are affected.
Siemens IMMULITE 2000 Anti-TG Ab thyroid test kits are recalled due to the potential for falsely elevated patient sample results. Affected lots may produce inaccurate results that could lead to misdiagnosis.
Siemens Healthcare Diagnostics is recalling certain IMMULITE 2000 Anti-TG Ab test kits due to the potential for falsely elevated thyroid antibody results in patient samples.
Bio-Rad Laboratories is recalling a diagnostic test kit due to incorrect calibrations and controls that may produce inaccurate test results. Patients and healthcare providers should contact the manufacturer.
Siemens is recalling its DCA HbA1c Reagent Kit because the device displays falsely elevated readings without alerting the user. This could lead to incorrect patient management of glucose levels.
Ortho-Clinical Diagnostics is recalling VITROS XT 3400 Chemistry Systems due to a software defect affecting quality control baseline statistics, which may cause inaccurate patient test results.
Randox Laboratories issued a technical bulletin stating that RX Series Copper Assay tests must not be run directly after Total Protein tests, as this could produce falsely elevated copper results.
Randox is recalling RANDOX Total Bilirubin reagent because reports indicate elevated patient results when using plasma samples with this reagent.
Siemens Healthcare Diagnostics has recalled the Atellica CH LDL Cholesterol Direct diagnostic device due to reagent carryover affecting magnesium test accuracy. Approximately 8420 units distributed nationwide and internationally are affected.
Siemens Healthcare Diagnostics is recalling epoc BGEM Test Cards for veterinary use due to potential inaccurate glucose results in lower-range samples. Affected units may report artificially elevated readings.
Beckman Coulter is recalling over 2 million Ringed DxI Reaction Vessels that may produce falsely elevated lab test results due to interior surface defects. The issue was discovered through internal service testing.
Siemens Healthcare is recalling 9,272 Atellica IM Folate 700 test kits due to negative bias in results when whole blood calibration is used to test serum samples.
Siemens Healthcare Diagnostics is recalling 7,884 ADVIA Centaur Folate 500 diagnostic test kits because using whole blood calibration with serum samples produces negative bias and inaccurate results.