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.
Healthmark Industries is recalling ProChek-II tests because they were manufactured with an expired ingredient, which may cause false negative or positive results.
Siemens Healthineers is recalling 24 units of the Immulite 2000 Syphilis Screen assay due to a potential negative patient bias that may report low reactive results as nonreactive.
Siemens Healthineers is recalling Immulite 2000 Syphilis Screen assays because a negative patient bias may cause low reactive results to be reported as nonreactive.
Hologic is recalling one master lot of the Aptima HPV Assay because the product exhibits potential to generate either invalid or false negative results.
Diagnostica Stago is recalling 438 Asserachrom HPIA kits from one lot because a potential defect can affect every well in an impacted strip and produce negative results.
Meridian Bioscience is recalling 211 units of the Revogene C. difficile assay because affected lots show a decline in performance over time, which may lead to false-negative results.
Enterix is recalling 201,426 InSure ONE Fecal Immunochemical Test kits after the test failed sensitivity testing with one test card lot, which may result in false negative results.
BioFire Diagnostics is recalling 23 kits of the BioFire Respiratory Panel 2.1 because unintended movement of pouch chemistry may cause false negative results and control failures.
Cepheid is recalling 4,132 Xpert SA Nasal Complete kits after post-market half-time stability testing produced a false negative result for a positive sample type.
FLEX Monoclonal Mouse Anti-Human CD20cy for Dako Omnis, catalog GA60461-2J, is recalled because of the potential for weak staining that may result in false negative CD20 identification. 67 units are affected.
FLEX Monoclonal Mouse Anti-Human CD20cy for Dako Omnis, catalog GA60461-2CN, is recalled because of the potential for weak staining that may result in false negative CD20 identification. 65 units are affected.
FLEX Monoclonal Mouse Anti-Human CD20cy for Dako Omnis is recalled because of the potential for weak staining, which may result in false negative CD20 identification. 4,145 units are affected.
DASH SARS-CoV-2 & Flu A/B Tests are being recalled because a manufacturing error means the assay may result in a missed diagnosis or delay of treatment through a potential false negative. 710 units affected.
Hologic Rapid fFN Specimen Collection Tubes from three lots may contain incorrect amounts of extraction buffer, potentially causing invalid test results or diagnostic errors in preterm delivery assessment.
Kreatech PapV-16 HPV-16 diagnostic probes are recalled for suboptimal DNA hybridization due to oversized DNA fragments. This may cause false positives or false negatives if proper laboratory controls are not used.
Siemens Healthcare is recalling certain IMMULITE 2000 PSA assay diagnostic kits because they do not perform as claimed for high-concentration samples used on IMMULITE 2000 analyzers.
Osom Ultra hCG pregnancy test kits are recalled due to false negative results. The devices failed to detect hCG in samples with confirmed hCG presence.
Healgen Scientific is recalling 1,636,994 urinalysis test strips in California, Georgia, and Texas due to reduced protein detection sensitivity that may produce false negative results and delay kidney disease diagnosis.
BioFire is recalling FILMARRAY TORCH modules because calibration errors may cause false positive or negative results for pathogens like Salmonella and MRSA.
BioFire Diagnostics is recalling FilmArray 2.0 diagnostic instruments that may have been incorrectly calibrated, leading to false positive and false negative results for infectious disease tests including Salmonella, Giardia, Norovirus, and MRSA.
Macherey Nagel urinalysis test strips are recalled due to a missing leukocytes test pad on some packages, potentially resulting in false negative results for urinary tract infections and renal inflammation. Affected lot: 65402.
Quidel Corporation is recalling 104,300 units of InflammaDry MMP-9 diagnostic tests due to misalignment of the test results window. Positive results may be hidden and not visible, potentially leading to false negative readings.
BD Biosciences is recalling CD11b APC diagnostic reagent vials that may produce dim fluorescence signals, potentially causing false negative results and misdiagnosis of blood cancers.
BioFire Diagnostics recalls 57 kits of the BIOFIRE Respiratory Panel 2.1 due to a manufacturing defect that may produce false negative results, potentially causing treatment delays or missing infections.
BioFire Diagnostics is recalling BIOFIRE Blood Culture Identification 2 (BCID2) Panels due to instrument characteristic changes that cause Candida tropicalis to be detected but reported as 'Not Detected' in quality control testing.