Hazard
55 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 55 false positive 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 4 (7%) are Severe.
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all false positive 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.
Abbott Molecular has recalled 71,314 units of the Alinity m SARS-CoV-2 Amp Kit due to potential false positive results. The kit was distributed worldwide.
Abbott Molecular recalls its Alinity m SARS-CoV-2 Amp Kit (Non-US Assay), an in vitro diagnostic test, due to potential for false positive results. Approximately 11,408 units were distributed worldwide.
Roche Molecular Systems is recalling cobas SARS-CoV-2 & Influenza A/B test kits following reports of increased false positive SARS-CoV-2 results.
Luminex Corporation is recalling 4,579 Verigene EP Amplification Reagent Kit Test units worldwide due to potential for false positive results. Affected kits distributed across the United States, Austria, France, Greece, Japan, and Turkey may produce incorrect test results.
Beckman Coulter is recalling ACCESS SARS-CoV-2 Antigen QC reagent due to false positive test results that could lead to incorrect diagnoses. The Class II recall affects 544 units distributed nationally and internationally.
NeuMoDx Molecular Inc. is recalling certain cartridge lots that may produce false positive diagnostic results. Affected healthcare providers should verify tests performed with these cartridges and contact the manufacturer for guidance.
Ortho-Clinical Diagnostics is recalling VITROS SARS-CoV-2 Antigen Reagent Packs used with Remel M4RT Viral Transport Media due to potential false reactive results.
LumiraDx is recalling specific lots of SARS-CoV-2 antigen test strips due to potential false positive results that could lead to unnecessary treatment or quarantine.
Roche is recalling cobas z 480 analyzers because a dirty lens may cause invalid or false positive results.
Quidel Corporation is recalling package inserts for the Sofia SARS Antigen FIA test because instructions referencing specific viral transport media may lead to false-positive results.
Becton Dickinson is recalling BD MAX SARS-CoV-2 Reagents due to elevated rates of potential false positive results, which could delay diagnosis and increase exposure risk.
Biomerieux Inc is recalling VITEK 2 Gram-positive Susceptibility Cards because they may produce false positive results for certain Staphylococcus aureus strains.
Siemens Healthcare Diagnostics Inc is recalling Stratus CS Acute Care cTNI TestPaks due to a potential for increased false positive results.
Abbott Ireland Diagnostics Division is recalling Alinity i Estradiol Reagent Kits because patient results may be falsely elevated for individuals treated with Mifepristone.
BioFire Diagnostics is recalling the FilmArray Gastrointestinal (GI) Panel due to elevated rates of false positive results for Campylobacter and Cryptosporidium.
BioFire Diagnostics is recalling FilmArray BCID Panels used with specific BACT/ALERT blood culture bottles due to an increased risk of false positive results for Enterobacteriaceae and E. coli.
Roche is recalling 12 units of the cobas p 612 pre-analytical system because sample material may contact the pipetting nozzle, potentially causing false positive test results.
Hyphen BioMed is voluntarily recalling ZYMUTEST HIA assays because they may produce false positive results. The recall affects specific lots distributed in the US, Austria, and France.
Meridian Bioscience is recalling Premier EHEC and Premier EHEC Bulk diagnostic kits because internal testing showed they can produce false positive results with some broth specimens.
Siemens is recalling specific lots of Rubella IgM assay kits because they may produce false positive or indeterminate results on certain analyzers.
Siemens is recalling specific lots of Rubella IgM assays due to increased false positive and indeterminate results.
Ortho-Clinical Diagnostics is recalling specific lots of VITROS Total Beta-hCG II Reagent Packs and Calibrators because they may generate false positive results for hCG levels.
Becton Dickinson is recalling seven BD Viper LT Systems due to the potential for false positive Chlamydia and Gonorrhea test results.
Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Lipase Reagent because carryover from other reagents can cause falsely elevated test results.
Siemens Healthcare Diagnostics is recalling Rapid Neg Urine Combo Panel Type 1 due to an increase in false positive susceptible results when used with MicroScan Microbiology Systems.