Hazard
72 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 72 false negative result recalls we have scored against our rubric, 1 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (6%) are Severe.
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all false negative result 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 is recalling 2,370 pouches of the BIOFIRE Respiratory Panel 2.1 test due to an increase in false negative results.
Biomerieux Inc is recalling VITEK 2 AST-N447 TEST KIT (Lot 0853293604) distributed internationally due to potential false resistant carbapenem and/or cephalosporin results when pouch foil fractures are present.
Luminex is recalling VERIGENE Gram Negative Blood Culture test cartridges due to a consumable issue that may produce incorrect results on a small portion of one lot.
Luminex is recalling the VERIGENE C. difficile diagnostic test due to the possibility of false-negative results in rare instances caused by hydrophobic characteristics in specific FLOQSwab lots.
Greer Laboratories recalled a hypersensitivity pneumonitis test kit (102 units, Lot 389592) after stability testing revealed decreased reactivity that could cause false-negative results. The issue was discovered in October 2021.
Luminex is recalling certain lots of the ARIES SARS-CoV-2 Assay because a defect in the wash 1 syringe could cause incomplete sample extraction and produce false negative test results.
A laboratory automation device's setup screen indicates minimal volume when the exact volume should be loaded, potentially causing over-diluted, under-diluted, or improperly prepared samples and false test results.
Qiagen Sciences LLC is recalling the therascreen KRAS RGQ PCR Kit due to potential false positive or false negative results in KRAS G12C mutation detection. These inaccurate results could invalidate clinical test outcomes.
BioMerieux MYLA diagnostic system software versions 4.7–4.8.2 may produce false negative results under certain conditions, potentially missing diagnoses. Affected units are being recalled worldwide.
Luminex Corporation is recalling 38,990 Verigene Respiratory Pathogens Flex nucleic acid tests due to potential false-negative results. The tests were distributed worldwide, including throughout the United States.
Luminex Corporation is recalling the Verigene BC-GP blood culture test (Model 20-006-018) due to the potential for false-negative results. Approximately 36,416 units have been distributed worldwide.
Luminex Corporation is recalling 17,110 units of the Verigene Gram Negative Blood Culture test (Model 20-006-021) due to potential false-negative results that may fail to detect Gram-negative bacterial infections.
Quidel Corporation is recalling approximately 29,787 kits of the Lyra SARS-CoV-2 Assay due to a theoretical risk that samples with very high viral loads could produce false negative results. No false negatives have been formally reported.
Roche Diagnostics is recalling 10,489 Troponin I STAT Immunoassay kits because they may produce false negative results when run after proBNP II tests on specific modules.
Roche Diagnostics is recalling 726 Elecsys Troponin I Immunoassay kits because they may produce false negative results when run immediately after proBNP II tests on specific modules.
Luminex is recalling VERIGENE Processor SP units because they may produce false-negative results for specific enteric pathogens when used with the VERIGENE Enteric Pathogens Nucleic Acid Test Kit.
Meridian Bioscience is recalling 8 ImmunoCard Mycoplasma EIA kits due to incorrect storage that could cause false-negative or invalid results, potentially delaying appropriate patient treatment.
Hologic is recalling 607 Panther Fusion Tube Trays because they may leak, potentially invalidating patient results or causing false negatives in flu and RSV assays.
Remel Europe Ltd. is recalling Thermo Scientific Remel Bordetella pertussis Agglutinating Serum because it may produce false negative results for serotypes 1 and 3.
Luminex is recalling Verigene Processor SP systems because an instrument failure may cause false negative results for Gram-positive and Gram-negative blood culture tests.
DiaSorin Molecular LLC is recalling Simplexa VZV Swab Direct kits due to a software malfunction that may cause false negative results.
Qiagen is recalling Rotor-Gene Q instruments with software version 2.3.4 because a bug causes concentration results to be reported as logarithmic values, potentially leading to false negative test results.
Abbott is recalling 83 kits of ARCHITECT HAVAB-G Calibrator, lot 08219BE00, because increased RLU values may cause false non-reactive patient results.
Luminex Molecular Diagnostics is recalling xTAG Respiratory Viral Panel kits because they may produce false negative results for Influenza A (H3) and RSV A.
Helena Laboratories is recalling 21 kits of Cascade Abrazo aPTT Test Cards, Model 5722, distributed to Germany and Australia, due to potential false negative results.