Hazard
171 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 171 false negative recalls we have scored against our rubric, 2 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (2%) are Severe.
Which agencies issued them
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all false negative 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.
Luminex Corporation is recalling 165 units of the Verigene BC-GNv2 diagnostic test worldwide due to the potential for false-negative results in blood culture testing.
BioFire Diagnostics is recalling 3,559 FilmArray Pneumonia Panel plus test kits globally due to stability failures causing increased false negative results between 6 and 12 months after manufacturing, potentially missing pneumonia diagnoses.
Luminex Corporation is recalling Verigene Enteric Pathogens diagnostic tests due to potential for false-negative results, which could miss serious bacterial infections.
The LeadCare II Blood Lead Test Kit may generate artificially low control test results, causing blood lead levels to be underestimated in patient samples. Kits were distributed worldwide.
Beckman Coulter is recalling Access SARS-CoV-2 Antigen test kits because specimens stored in certain conditions may yield false negative results.
Meridian Bioscience is recalling 376 Revogene SARS-CoV-2 test kits because the FDA withdrew the Emergency Use Application after false negative results were reported.
Meridian Bioscience is recalling 124 Revogene RNA Software Upgrade Kits because the FDA withdrew the Emergency Use Application after false negative results were reported.
Becton Dickinson is recalling 938 kits of BioGX SARS-CoV-2 Reagents because some master mix pouches may be mislabeled, potentially leading to false negative test results.
Hardy Diagnostics is recalling Viral Transport Media due to potential contamination that may compromise COVID-19 test detection.
Clinical Innovations is recalling ROM Plus Collection Kits because incorrect swabs may cause false test results.
Siemens Healthcare Diagnostics is recalling specific HER-2/neu assay kits and calibrators because the Upper Limit of Normal was not achieved, potentially causing false positive or negative results.
Life Technologies is recalling the TaqPath RT-PCR COVID-19 Kit due to software issues that may cause invalid, inconclusive, or false test results.
Life Technologies is recalling the TaqPath RT-PCR COVID-19 Kit due to software issues that may cause invalid, inconclusive, or false test results.
Luminex is recalling Verigene Processor SP systems because an instrument failure may cause false negative results in blood culture tests.
Ortho Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 IgG Reagent Packs because swapped reagent bottles may cause false negative or delayed results.
Ortho Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 Total Reagent because swapped bottles may cause false negative or delayed results.
DiaSorin Molecular LLC is recalling Simplexa VZV Direct test kits due to a software malfunction that may cause false negative results for varicella-zoster virus.
DiaSorin Molecular LLC is recalling Simplexa HSV 1&2 Direct test kits because a software malfunction may cause false negative results.
Siemens is recalling 927 Atellica Solution IM1300 Analyzers because they may fail to detect insufficient samples when using specific sample cups.
Merge Healthcare is recalling specific versions of Merge Cardio software due to a calculation error that may produce false negative Z-Scores.
Hologic is recalling Panther Fusion Extraction Reagent-S kits because a reagent component may cause false positive or negative flu test results, potentially delaying treatment.
Beckman Coulter is recalling SYNCHRON Systems Barbiturates Reagent because cross-reactivity testing may not meet claims, potentially causing false positive or negative results.
Beckman Coulter is recalling Opiate 300 Ng Reagent because cross-reactivity testing may not meet claims, potentially causing false positive or negative urine test results.
Beckman Coulter is recalling Synchron Opiate 2000 ng Reagent because cross-reactivity testing may not meet instructions for use, potentially causing false positive or negative urine test results.
BioFire Diagnostics is recalling FilmArray Gastrointestinal Panel kits due to elevated false negative rates that may lead to incorrect treatment.