Hazard
41 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 41 diagnostic failure recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (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 diagnostic failure 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.
Luminex Corporation is recalling 4 Verigene Processor SP diagnostic devices that repeatedly failed to produce results, returning No Call outputs instead. Two of three customer complaints involved this malfunction.
Hologic is recalling 2,061 Panther Fusion GBS Assay Cartridges because samples at or near the limit of detection may produce false negative results, risking missed diagnosis of group B streptococcus infection.
Siemens Healthcare Diagnostics is recalling 261 ADVIA Centaur SARS-CoV-2 Antigen Assay test kits distributed nationwide because the FDA determined that validation data submitted for emergency authorization was insufficient to confirm the assay's effectiveness.
GE Healthcare is recalling Optima MR450w 1.5T MRI systems due to a software issue in version DV29.1 that may cause missing image slices, creating gaps in 3D scans that could affect diagnostic accuracy.
Canon Medical System is recalling three Canon PET-CT Scanner units due to a software flaw that prevents automatic scan progression. This malfunction could cause diagnostic failures requiring unnecessary rescanning and contrast medium reinjection.
Abbott is recalling Vysis CLL FISH Probe Kits that may not detect 13q deletions in patient samples. This could lead to missed diagnosis of a genetic abnormality used in cancer treatment planning.
BioFire Diagnostics is recalling 3,559 FilmArray Pneumonia Panel plus test kits globally due to stability failures causing increased false negative results between 6 and 12 months after manufacturing, potentially missing pneumonia diagnoses.
Luminex Corporation is recalling 1,261 Verigene Clostridium difficile test kits due to potential for false-negative results. The kits may fail to detect C. difficile infections, potentially delaying diagnosis.
Pacific Medical Group is recalling 1,603 External Toco Transducers serviced with non-OEM parts that were not appropriately verified or validated.
Bard Peripheral Vascular Inc is recalling EnCor Breast Biopsy Probes due to increased complaints about leaks, suction problems, and failure to obtain tissue samples.
Natus Neurology is recalling 2,335 Elite Obstetric probes because excessive background noise may mask heart rate and blood flow sounds.
Merge Healthcare is recalling 182 Eye Station capture stations because they may fail to capture eye images as intended, posing a risk to patient health.
Philips Healthcare is recalling five DuraDiagnost stationary X-ray systems because the detector may incorrectly signal readiness, causing failed image acquisitions.
Remel Inc is recalling Legionella BCYE Growth Supplement because it may fail to recover Legionella pneumophila, leading to false negative identification.
Remel Inc. is recalling specific lots of Thermo Scientific VersaTREK REDOX 1 in vitro diagnostic products because they failed to provide positive signals for Streptococcus pneumoniae.
Life Technologies is recalling 15 kits of HSV-2 Primers because they failed to amplify HSV-2 DNA. The products were distributed in Delaware, Iowa, Minnesota, and North Carolina.