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.
Siemens Healthineers is recalling Immulite 2000 Syphilis Screen assays because a negative patient bias may cause low reactive results to be reported as nonreactive.
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.
Instrumentation Laboratory is recalling the GEM Premier 5000 portable blood analyzer system because bar code reader wands may assign patient results to the wrong patient ID. The recall affects 21 units distributed nationwide.
Philips is recalling certain CT scanners because the clinical scan may not start automatically after Bolus Tracking, which could require a patient rescan and expose them to additional radiation.
Philips is recalling IQon Spectral CT systems because the clinical scan may not start automatically after Bolus Tracking, requiring manual triggering and potentially causing extra radiation exposure.
Instrumentation Laboratory is recalling the GEM Premier 5000 blood analyzer system because bar code reader wands may assign patient results to the wrong patient ID. The FDA has classified this as a Class II recall.
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.
Foundation Medicine is recalling Sequencing Agent SEQ0067, a component of the FoundationOne CDx test, due to a possible increase in phasing that could result in false-positive BARD1 splice site indel artifact variants.
Beckman Coulter is recalling Access Total T4 Calibrator lots because they produce falsely low patient results on DxI 600/800 instruments, potentially leading to unnecessary testing, delayed treatment for thyroid disorders, and incorrect dosing in pregnant patients.
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.
Philips is recalling Vue Motion V12 because mis-ordered frames during dynamic cine runs may cause image frames to display out of sequence.
Siemens is recalling Atellica CH Enzymatic Hemoglobin A1c because results may be depressed when the RCRP reagent is processed on the same analyzer, with bias increasing over time.
Oxoid, part of Thermo Fisher Scientific, is recalling one lot of the Microbact 12L Listeria identification kit because it may identify the incorrect organism.
Diagnostica Stago is recalling the STA Liatest D-Di kit after investigations confirmed a positive bias in D-dimer measurements throughout the entire analytical range.
Hologic is recalling one master lot of the Aptima HPV Assay because the product exhibits potential to generate either invalid or false negative results.
Abbott is recalling one lot of the ID NOW Influenza A & B 2 test after confirming the lot has a higher occurrence of invalid rates than stated in the Instructions for Use.
Diagnostica Stago is recalling four lots of the STA Liatest Free Protein S kit because of the potential for out-of-range results and underestimation of free protein S in normal patient plasmas.
GE Healthcare is recalling Centricity Universal Viewer Zero Footprint Client because under certain workflows the patient information shown may not match the images displayed.
Siemens Healthcare Diagnostics is recalling all lots of the Atellica CH Urine Albumin assay because falsely depressed patient results may occur above the measuring interval.
Roche is recalling cobas pro sample supply units on software versions before 03-02 because a defect can make the analyzer repeat the last calculated result for all later measurements.
GE is recalling 65 LOGIQ P10 series systems running software R4.5.7 because the Ultrasound-Guided Attenuation Parameter measurement may display inaccurate liver steatosis values.
GE is recalling 37 LOGIQ P9 R4.5 ultrasound systems running software R4.5.7 because the Ultrasound-Guided Attenuation Parameter measurement may display inaccurate liver steatosis values.
GE is recalling 31 LOGIQ P10 R4.5 HD ultrasound systems running software R4.5.7 because the Ultrasound-Guided Attenuation Parameter measurement may display inaccurate liver steatosis values.
Change Healthcare is recalling 12 programs running Radiology Solutions software version 14.2.2 because a software issue means radiology reports may not be fully displayed.
MedicalCommunications GmbH is recalling 474 units of HEYEX 2 / HEYEX PACS software because a measured value may be smaller than the actual area.