Hazard
54 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 54 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 3 (6%) 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.
Quidel Corporation is recalling the QuickVue Dipstick Strep A Test (50T, REF 20108) due to the potential for false positive results. The product was distributed nationwide.
Magellan Diagnostics is recalling LeadCare Plus Blood Lead Test Kits (Catalog Number 82-0004) because they may produce falsely elevated lead results when used with certain third-party micro-collection devices, potentially causing delayed testing and unnecessary follow-up testing.
Magellan Diagnostics is recalling the LeadCare Ultra Blood Lead Test Kit (Catalog Number 70-8098) because use with certain third-party micro-collection devices may produce unexpectedly elevated and false positive results, potentially causing delayed diagnosis and unnecessary additional testing.
Magellan Diagnostics is recalling LeadCare II Blood Lead Test Kits because certain third-party micro-collection devices may produce falsely elevated lead results, potentially causing unnecessary testing and delayed results.
Ortho-Clinical Diagnostics is recalling the Solana Bordetella Complete Assay Kit (Model M308) because it may produce false positive results for Bordetella parapertussis at a rate of up to 16.7%.
Abbott Molecular is recalling the Alinity m Resp-4-Plex AMP Kit (List Number 09N79-096) due to reports of increased reactive negative controls and false positive results in respiratory viral testing.
Abbott Molecular is recalling the Alinity m Resp-4-Plex Amplification Kit due to reports of reactive negative controls and false positive results in respiratory virus testing.
Hologic is recalling specific lots of the Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay due to potential false positive SARS-CoV-2 results. Users should verify positive results with an alternative testing method.
The NxTAG Respiratory Pathogen Panel is recalled due to false positive results for human metapneumovirus in about 7.6% of samples, especially those positive for other respiratory pathogens.
Ventana Medical Systems recalls its anti-CD10 (SP67) rabbit monoclonal antibody due to potential high background and off-target staining that could produce false positive test results. Approximately 22,839 kits distributed worldwide are affected.
BioFire Diagnostics is recalling gastrointestinal diagnostic test kits due to false positive Vibrio results when used with certain transport mediums.
Luminex recalls approximately 1,100 diagnostic kits due to defective test cartridges that may produce false positive results for Staphylococcus lugdunensis and Enterococcus faecium bacteria.
Abbott is recalling the Alinity i Anti-HCV Reagent Kit (5110 units) due to potential false-positive test results when syphilis testing precedes the HCV test on the same instrument. Customer complaints and internal studies confirmed the interaction that may produce falsely elevated results.
PTW-FREIBURG's VERIQA software (versions 2.0 and 2.1) may incorrectly calculate gamma passing rates when users exclude voxels below a dose threshold, potentially displaying false positive dose evaluation results.
BioFire Diagnostics is recalling FilmArray GI diagnostic test kits due to potential signals of increased false positive Norovirus results. Approximately 64,594 kits representing 2.3 million tests have been distributed worldwide.
BioFire Diagnostics is recalling FilmArray Pneumonia Panel Plus diagnostic test kits due to a potential for false positive results. These inaccurate results could lead to incorrect pneumonia diagnoses.
Phadia Ab recalls 124,928 EliA GBM Wells diagnostic kits distributed nationwide due to complaints of false positive results. The wells produced unexpected positive signals in samples tested without antigen.
BioFire Diagnostics is recalling FILMARRAY Gastrointestinal Panel software due to an increased risk of false positive Cryptosporidium test results. Approximately 61,069 devices were distributed in the US and internationally.
Randox Laboratories is recalling CRP Immunoturbidimetric reagent Batch 588434 because the antibody component shows a positive bias on patient samples, producing elevated test results compared to previous batches. Quality control samples remain within acceptable range.
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.
Accelerate Diagnostics is recalling the Accelerate PhenoTest BC kit due to improperly formulated FISH probes that produce false positive identification results for Staphylococcus aureus and Streptococcus species. Approximately 7,160 kits have been distributed across the United States and internationally.
Menarini Silicon Biosystems is recalling CELLSEARCH Circulating Tumor Cell Kit due to potential false positive results in patient samples. The device may generate unassigned events that could affect diagnostic accuracy.
BioFire Blood Culture Identification 2 (BCID2) diagnostic panels are being recalled due to increased risk of false positive Acinetobacter calcoaceticus-baumannii results caused by non-viable contamination in blood culture vials.
Bio-Rad is recalling 11,610 units of BioPlex 2200 syphilis test reagent packs because they can produce false positive results that don't confirm with follow-up tests, due to elevated reactivity and shelf-life issues.
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.