Hazard
28 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 28 test accuracy 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 test accuracy 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.
Abbott Rapid DX Multi Analyte Level 1 & 2 control products were exposed to temperatures outside recommended storage conditions due to transit delays caused by severe thunderstorms, which may result in incorrect or delayed test results.
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.
Abbott Diagnostics is recalling certain lots of the ID NOW COVID-19 2.0 24T test device due to higher-than-expected rates of invalid test results. The affected devices were distributed nationwide.
Microbiologics Inc is recalling Helix Elite Inactivated SARS-CoV-2 quality control material (Lot HE0065-29) because the A549 human cell target may produce late Ct values, potentially affecting test result validity.
Instrumentation Laboratory is removing the HemosIL Liquid Anti-Xa test definition from ACL Elite/Elite Pro Analyzers. This affects 358 units in the US and 558 units internationally.
Immuno-Mycologics recalls 411 Cryptococcal Antigen test kits (lots F1021035, F1021036) for reduced specificity (90% vs. 99%), which may cause false-positive results leading to unnecessary anti-fungal therapy.
Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Direct Bilirubin assays because they may show positive bias in patients taking eltrombopag.
Siemens Healthcare Diagnostics is recalling Atellica IM 1600 Analyzers running software versions V1.19.0 and V1.19.2 due to issues scanning new reagent lot test definitions.
Siemens Healthcare Diagnostics is recalling 114 Atellica IM aTG test kits because they show positive bias compared to WHO standards.
Roche Diagnostics is recalling Bilirubin Total Gen.3 assays due to new endogenous interference claims that may pose a potential medical risk.
Roche Diagnostics is recalling 656 COBAS INTEGRA 400 plus analyzers because specific tests require additional wash cycles to prevent carry-over.
Ortho-Clinical Diagnostics is recalling VITROS Anti-HBe Reagent Packs because biased results may occur at lower biotin concentrations than indicated in the instructions.
Becton Dickinson is recalling BD Vacutainer Urine Collection Cups because they may cause slight elevations in red blood cell counts when used with specific analyzers.
Ortho Clinical Diagnostics is recalling VITROS TSH Reagent Packs because biotin supplements may cause biased test results at lower concentrations than stated in the instructions.
Ortho Clinical Diagnostics is recalling VITROS Folate Reagent Packs because biotin supplements may cause biased test results at lower concentrations than stated.
bioMerieux, Inc. is recalling VIDAS LH test kits because internal tests confirmed a decrease in strip signal over time, leading to invalid calibration results.
BioMérieux is recalling VIDAS TOXO IgG Avidity tests because a shipment to Guadeloupe exceeded temperature limits. The products were delivered to customers despite quarantine instructions.
BioMérieux is recalling VITEK 2 Gram Positive Susceptibility Cards in Guadeloupe because a shipment experienced a temperature excursion up to 47.8°C, exceeding acceptable limits.
Phadia US Inc is recalling 70 Phadia 1000 Instruments nationwide because a malfunctioning Retry command may cause solution shortages and affect test results.
Cell Marque is recalling specific lots of SIOOA I Rabbit Monoclonal Antibody due to unacceptable IHC test results. The affected units were distributed in the US and several international countries.
Siemens Healthcare Diagnostics is recalling 87 ADVIA Chemistry XPT Systems due to software defects that may cause test failures, calibration errors, and system restarts.
Becton, Dickinson and Company is recalling FMC7 FITC reagents because functional degradation reduces the percent positive from 100% to approximately 87%.
Ameditech is recalling Immutest 10 Pnl Drug Screen Cups because they may show reduced reactivity for two specific benzodiazepine compounds.
Ameditech is recalling 10,320 CLIA RDTC 12-Panel Cup kits nationwide because they may show reduced reactivity for Clonazepam and Chlordiazepoxide.
Pointe Scientific is recalling G6PD Controls due to reduced reconstituted stability that may cause out-of-specification results.