Hazard
397 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 397 diagnostic error recalls we have scored against our rubric, 1 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 12 (3%) are Severe.
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all diagnostic error 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.
Roche is recalling COBAS TaqMan MTB Test Definition Files due to an incorrect cutoff value that may cause false negative results for tuberculosis tests.
Becton Dickinson is recalling specific blood collection tubes due to reports of extended Partial Thromboplastin Time (aPTT) test results.
Roche Diagnostics is recalling 78 Cobas 8000 Modular Analyzers because a probe positioning mismatch can cause insufficient reagent pipetting, potentially affecting test results.
Sysmex America is recalling 763 XE-5000 automated hematology systems because reticulocyte counts may be 21% lower than expected due to a low bias.
Sysmex America is recalling 69 XE-2100C automated hematology systems because reticulocyte counts may be 21% lower than expected.
Advandx Inc is recalling 187 GNR Traffic Light PNA FISH kits because they may produce false positive results for Pseudomonas putida and Pseudomonas fulva.
Toshiba American Medical Systems is recalling three Aquilion One CT systems because the SureStart function may fail, leading to abnormal cerebral blood flow analysis results.
Instrumentation Laboratory is recalling ACL TOP 700 analyzers because they may report abnormal fibrinogen levels as normal or low levels as high.
Instrumentation Laboratory is recalling ACL TOP analyzers because they may report abnormal fibrinogen levels as normal or vice versa, potentially affecting clinical decisions.
Instrumentation Laboratory is recalling ACL TOP 700 CTS analyzers because they may incorrectly report abnormal fibrinogen levels as normal or low.
Bio-Rad Laboratories is recalling MONOLISA Anti-HBs EIA kits because light exposure to the Conjugate Diluent may cause false positive or grey zone results.
Princeton Biomeditech is recalling 90 kits of the Status Flu A + B Test due to reports of dual positive results.
Princeton Biomeditech is recalling Orasure QuickFlu Rapid A+B Test kits due to reports of dual positive results for Flu A and Flu B.
Princeton Biomeditech Corp is recalling 103 kits of the Poly stat Flu A & B Test due to reports of dual positive results.
Hitachi is recalling MRI software due to a defect that may reverse the orientation of the first image in a dataset.
Siemens is recalling ADVIA Centaur Syphilis Assay kits because they may interfere with Hepatitis B surface antigen testing, potentially affecting diagnostic accuracy.
Siemens is recalling 15 syngo Lab Data Manager units because they may display and transmit incorrect coagulation results to laboratory information systems.
Greiner Bio-One is recalling specific lots of 3mL coagulation blood collection tubes because a lower citrate concentration may cause falsely low test results.
Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry System Software due to a defect that prevents proper quality assessment verification when reagent lots are switched.
Becton Dickinson is recalling Gram Crystal Violet 250 mL reagents due to potential artifacts that may interfere with the identification of microorganisms.
Alere San Diego is recalling 1,972 Triage D-dimer kits because certain lots may have decreased precision, potentially leading to false positive or negative results.
Philips Healthcare Inc. is recalling Digital Diagnost Software releases 2.0.2 and 2.0.2SP1 because a mirrored image marker can be mistaken for a right-side patient indicator.