Hazard
170 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
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.
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.
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.
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.
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 AneurysmFlow software is recalled because the Mean Aneurysm Flow Amplitude (MAFA) ratio does not reliably indicate aneurysm treatment success, yet physicians are relying on it for clinical decisions.
Beckman Coulter is recalling MicroScan Neg Multidrug Resistant test kits due to incorrect manufacturing processing of the in vitro antimicrobial test. The defect may affect diagnostic accuracy.
Beckman Coulter is recalling MicroScan Neg MIC 3J diagnostic panels due to manufacturing errors affecting test accuracy. One well per panel is missing a required drug while others contain double the intended amount of antibiotics.
Abbott is recalling ID NOW Influenza A & B 2 diagnostic tests nationwide due to higher-than-expected rates of invalid results in one lot. Affected persons should consult their healthcare provider about their test results.
A software error in the CellMek SPS Sample Preparation System causes samples to be dispensed incorrectly, resulting in sample loss of 60-100 microliters. This could lead to incorrect laboratory results and patient management decisions.
Menopause test cassette distributed before FDA approval recalled due to risk of false or inaccurate diagnostic results that could lead to inappropriate medical intervention.
Philips MR 7700 MRI systems with software versions R11.1 and R12.1 may display incorrect stiffness values when MR Elastography images are exported to medical imaging systems, potentially leading to diagnostic errors.
Roche is recalling 1,300 cassettes of the Elecsys Anti-TSHR immunoassay due to inconsistent test results across instrument platforms and lot-to-lot calibrator variability. These issues may cause delayed or incorrect diagnosis and treatment.
Intelerad InteleShare medical imaging software versions 3.24.3–3.25.2 contain a bug causing inaccurate measurement values when multiplanar reconstruction and manual rotation are used together. This could compromise diagnostic accuracy and potentially lead to misdiagnosis.
The FDA is recalling DermaSensor Model 10101 because it may not meet performance specifications, potentially causing incorrect diagnostic results or delayed referrals for patients with suspected skin cancer.
Siemens 3gAllergy Specific IgE Kit units have barcode orientation issues preventing correct tube scanning. With IMMULITE/Zebra scanners, the system cannot recognize proper tube position, risking incorrect allergen test results.
Beckman Coulter is recalling SYNCHRON Systems Direct LDL Cholesterol Reagent lot M404166 due to an increased probability of generating false high results, which could affect patient diagnosis and treatment.
Beckman Coulter's CellMek SPS Sample Preparation System has incorrect dead volume specifications in its instructions and a software defect affecting specimen processing. The errors may lead to incorrect diagnoses or errors in patient management.
Beckman Coulter DxI 9000 Access Immunoassay Analyzers have a software anomaly that may prevent correct application of manual dilution factors, potentially resulting in false high or low patient test results.
Beckman Coulter clinical laboratory analyzers have a software defect that may prevent correct application of dilution factors to patient samples, potentially producing false test results and diagnostic errors.
GE Medical Systems is recalling LOGIQ P10 series ultrasound systems because the liver steatosis measurement feature may display inaccurate values, potentially leading to incorrect clinical decisions.
GE Medical Systems' LOGIQ P10 R4.5 HD ultrasound system may display inaccurate liver steatosis measurements, potentially leading to inappropriate clinical decisions.
GE Medical Systems is recalling 37 LOGIQ P9 R4.5 ultrasound systems because the UGAP measurement feature may display inaccurate values for liver steatosis, potentially leading to inappropriate clinical decisions.
The FlexLab X in vitro diagnostic system includes a Sample Integrity Module function for detecting hemolysis, icterus, and lipemia in blood samples that was not evaluated by the FDA. Its use may produce erroneous test results or delays in patient results.
Agilent is recalling FLEX Monoclonal Anti-Human CD20cy antibody due to weak staining that may result in false negative B-cell identification. About 4,145 units were distributed nationwide.
Siemens Healthcare's Atellica CH urinary and cerebrospinal fluid protein test (11,811 units) may produce falsely depressed results in patient samples and quality control materials. Affected laboratories should verify test results and contact the manufacturer.