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.
Biomerieux's ETEST IMIPENEM RELEBACTAM diagnostic test produces major errors when testing Pseudomonas aeruginosa, incorrectly identifying resistant strains as susceptible. Approximately 1,431 units distributed worldwide.
Beckman Coulter is recalling its ACCESS SARS-CoV-2 Antigen test (REF C68668) because it may produce false positive results, potentially leading to incorrect diagnoses.
Beckman Coulter is recalling Access SARS-CoV-2 Antigen Calibrators because the assay test may generate false positive results, potentially leading to incorrect diagnosis. Approximately 451 units were distributed nationwide and internationally.
Beckman Coulter is recalling ACCESS SARS-CoV-2 Antigen QC reagent due to false positive test results that could lead to incorrect diagnoses. The Class II recall affects 544 units distributed nationally and internationally.
Abbott's A-ALT laboratory reagent may produce inaccurate results in samples with very high enzyme levels or elevated bilirubin, potentially affecting patient diagnoses. The affected product (REF 8L92-21) was distributed worldwide.
GE Healthcare recalls 311 SIGNA Architect MRI scanners due to button confusion that may result in flipped diagnostic images. The 'Patient Orientation' button may be accidentally clicked instead of 'Save RX', causing incorrect image orientation.
GE Healthcare recalls 460 SIGNA Pioneer MRI scanners worldwide due to a control panel button design flaw. Patient Orientation button may be accidentally clicked instead of Save RX, potentially resulting in incorrect image annotation or orientation.
GE Healthcare recalls 91 SIGNA HDxt MRI systems worldwide. The Patient Orientation button may be accidentally clicked instead of Save RX, potentially causing diagnostic images to be incorrectly oriented or flipped.
Luminex Corporation is recalling 165 units of the Verigene BC-GNv2 diagnostic test worldwide due to the potential for false-negative results in blood culture testing.
Luminex Corporation is recalling 38,990 Verigene Respiratory Pathogens Flex nucleic acid tests due to potential false-negative results. The tests were distributed worldwide, including throughout the United States.
Siemens Healthcare is recalling certain ADVIA Chemistry XPT systems with software version 1.4 or lower due to a default mixer failure detection setting that may allow incorrect patient lab results to be reported without alerting clinicians.
NeuMoDx Molecular Inc. is recalling certain cartridge lots that may produce false positive diagnostic results. Affected healthcare providers should verify tests performed with these cartridges and contact the manufacturer for guidance.
Quidel Corporation is recalling approximately 29,787 kits of the Lyra SARS-CoV-2 Assay due to a theoretical risk that samples with very high viral loads could produce false negative results. No false negatives have been formally reported.
Roche Diagnostics is recalling 10,489 Troponin I STAT Immunoassay kits because they may produce false negative results when run after proBNP II tests on specific modules.
Luminex is recalling VERIGENE Processor SP units because they may produce false-negative results for specific enteric pathogens when used with the VERIGENE Enteric Pathogens Nucleic Acid Test Kit.
Siemens Healthcare Diagnostics is recalling BCS XP Systems due to a potential risk of Emicizumab carryover on patient samples.
Siemens is recalling 15 ADVIA 2120i automated hematology analyzers because a software defect may cause sample identification mismatches with 14-character barcodes.
Siemens Healthcare Diagnostics is recalling 8 ADVIA 2120i automated hematology analyzers due to a potential sample identification mismatch with 14-character barcodes.
Diasorin Inc. is recalling LIAISON 1-84 PTH Assay kits because the system may produce falsely elevated parathyroid hormone results.
Siemens is recalling ADVIA Centaur4P Herpes-2 IgG test kits due to stability and calibration failures that may cause false positive results.
Phadia US Inc is recalling EliA dsDNA Well kits because decreased positive control values may cause false positive test results for systemic lupus erythematosus.
Hardy Diagnostics is recalling specific lots of Brain Heart Infusion Agar plates because they failed to inhibit Staphylococcus aureus as required.
Ortho Clinical Diagnostics is recalling VITROS CKMB Slides because CK-MM interference may cause falsely elevated creatine kinase MB results.
Becton Dickinson is recalling the BD Phoenix PMIC/ID-107 in vitro diagnostic device because it may produce false resistant results for S. aureus, potentially affecting antibiotic treatment.
Irvine Biomedical is recalling 40 units of Inquiry Steerable Diagnostic Catheters because packages were mislabeled with the wrong model and lot numbers, potentially causing procedure delays.