Hazard
23 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 23 false negative results recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all false negative 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.
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.
BD COR System Software version 8.80 and above is being recalled because of a potential functionality issue supporting the Over labeling feature that could lead to possible false negative results. 7 systems affected.
BioFire Diagnostics is recalling BioFire Respiratory Panel 2.1 plus Kit (Lot# 1475424) due to a manufacturing error that may cause elevated control failures and false negative test results.
BioFire Diagnostics is recalling 29 units of the FilmArra Pneumonia Panel Plus test kit due to control failures and false negative results. Affected units (Lot 0979424) were distributed to France, Italy, Spain, Switzerland, and Israel.
Immuno-Mycologics' Candida ID Antigen may have reduced sensitivity, causing false negative diagnostic results. Lot F4171005 has been distributed worldwide including CA and OK.
Becton Dickinson is recalling 2,061 kits of BD SARS-CoV-2 Reagents for BD MAX Systems because they may produce false negative results due to decreased enzyme activity. The kits were distributed nationwide and internationally.
Quidel InflammaDry MMP-9 test kits are recalled because the test results window is misaligned. Positive results may be hidden from view, potentially causing false negative readings.
BioFire FILMARRAY GI Panel diagnostic test kits may return false negative results due to a manufacturing event, potentially leading to missed diagnoses and inappropriate treatment. The affected kits were distributed to locations in 16 U.S. states.
ORTHO-CLINICAL DIAGNOSTICS is recalling VITROS Troponin I ES Reagent Pack due to potential incorrect wells that could generate false negative diagnostic results. Lot 4800 with expiration 10-Jun-2023 is affected.
Roche Molecular Systems is recalling its cobas Influenza A/B & SARS-CoV-2 test because it has reported false negative results for Influenza A, which may delay diagnosis and treatment.
Abbott Molecular is recalling specific lots of the Alinity m Resp-4-Plex Amp Kit due to reports of false positive and false negative test results.
Luminex Corporation is recalling VERIGENE Enteric Pathogens tests worldwide due to potential false negative results caused by hydrophobic characteristics of the sampling swab. The defect could lead to missed detection of infections in stool specimens.
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.
Luminex Corporation is recalling 24 Verigene Processor SP units because the heater may operate outside established temperature limits, potentially producing false negative diagnostic results.
Hologic is recalling 2,061 Panther Fusion GBS Assay Cartridges because samples at or near the limit of detection may produce false negative results, risking missed diagnosis of group B streptococcus infection.
Hologic is recalling Panther Fusion Extraction Reagent-X kits due to failed stability specifications that may cause false negative test results. Healthcare providers should stop using affected lots.
Roche Diagnostics is recalling the Cobas u 601 urinalysis test system due to potential false negative nitrite results when endogenous creatinine levels exceed 15,000 mg/L. The device may fail to detect nitrite in urine samples with elevated creatinine.
BioFire Diagnostics is recalling FilmArray Pneumonia Panel test kits globally due to stability failures that increase false negative results between 6 and 12 months of shelf life.
Dako is recalling 796 Autostainer instruments because a missing syringe tray may cause excess buffer application, potentially leading to false negative staining results.
Roche Diagnostics is recalling 14,398 URISYS 1100 Urine Analyzers because limits of detection for certain parameters were higher than listed, potentially causing false negative results.
Remel Inc is recalling Oxoid Nitrocefin reagents because individual bottles may produce weak reactions, leading to delayed or false negative beta-lactamase test results.
Becton Dickinson is recalling two BD BACTEC FX 40 instruments because a defective component may cause false negative results in clinical specimens.
Becton Dickinson is recalling BBL Fildes Enrichment tubes because they may fail to support the growth of Haemophilus species, potentially affecting laboratory test results.