Hazard
67 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 67 mis diagnosis recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 7 (10%) are Severe.
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all mis diagnosis 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.
Volcano Corp is recalling 19 Philips IntraSight Plus systems because software may incorrectly associate patient image data with the wrong medical record.
Bioporto Diagnostics is recalling ProNephro AKI Reagent Kits because a non-validated rework process could lead to missed diagnoses of renal disease.
Biofire Defense is recalling FilmArray NGDS Warrior Panel kits because the test may not correctly identify certain outbreak strains due to mismatches with the reference strain used during development.
Nuclein LLC is recalling the DASH Rapid PCR Instrument (Model SG-0002) because a software issue may result in false co-infection readings.
Cytocell Ltd. is recalling CytoCell DiGeorge/VCFS genetic probes that may display unexpected chromosome signals, potentially causing misdiagnosis. Affected reagents were distributed to laboratories in multiple US states and Canada.
Roche Diagnostics is recalling 726 Elecsys Troponin I Immunoassay kits because they may produce false negative results when run immediately after proBNP II tests on specific modules.
GE Healthcare is recalling 112 units of Centricity Universal Viewer software because a specific configuration may display comparison exams from the wrong patient.
Siemens is recalling 12 Ysio X.pree digital X-ray systems because a software issue may display a previous patient's image during recovery, potentially impacting diagnosis.
BioFire Diagnostics is recalling BCID2 Panels due to a risk of false positive Pseudomonas aeruginosa results when used with specific BD BACTEC blood culture vials.
Qiagen is recalling 1,474 QIAstat-Dx Respiratory SARS-CoV-2 Panel kits due to an increased rate of false positive results for Influenza A, which may lead to inappropriate antiviral use or delayed diagnosis.
Chembio Diagnostics is recalling 126 DPP Micro Reader kits because the FDA revoked their Emergency Use Authorization due to performance issues.
DiaSorin Molecular LLC is recalling Simplexa VZV Direct test kits due to a software malfunction that may cause false negative results for varicella-zoster virus.
Preventice Services is recalling eight BodyGuardian Heart Remote Monitoring Kits because unvalidated software may cause inaccurate data collection, making patient reports unreliable for condition evaluation.
Hardy Diagnostics is recalling HardyCHROM MRSA kits because they may produce false positive results for methicillin-susceptible Staphylococcus aureus.
Beckman Coulter is recalling Access Free T4 Thyroxine assays because biotin can cause significant result bias, potentially affecting patient care.
FDA is recalling Dover silicone Foley catheters with temperature sensors that failed to meet calibration standards, posing a risk of incorrect patient diagnosis.
Covidien is recalling Dover 100% Silicone Foley trays because the temperature sensors failed to meet calibration standards, potentially leading to incorrect patient diagnoses.
FDA recalls 468 Dover Foley catheters with temperature sensors that failed accuracy tests. Incorrect readings could lead to misdiagnosis.
FDA is recalling Dover silicone Foley catheters because temperature sensors failed to meet calibration standards, risking incorrect patient diagnoses.
Siemens Healthcare Diagnostics is recalling IMMULITE 2000 Estradiol test kits due to high discordant results that may lead to misinterpretation of patient menopausal status.
Siemens Healthcare Diagnostics is recalling IMMULITE 1000 Estradiol kits due to high discordant results that may lead to misinterpretation of patient menopausal status.
Life Technologies is recalling Torrent Suite Dx software because it may incorrectly display positive results for clinical variants.
Becton, Dickinson and Company is recalling eight BD FACSLyric Flow Cytometers because they may produce falsely high absolute counts when used with BD Trucount Tubes.
Bio-Rad Laboratories is recalling MRSASelect II diagnostic plates due to abnormal agar coloration and non-characteristic colony growth. The recall covers 3,632 units distributed nationwide.
Beckman Coulter is recalling 341 UniCel DxH 900 hematology analyzers because they may produce erroneously elevated platelet results without warning, potentially masking low platelet counts.