Hazard
79 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 79 calibration 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 0 (0%) are Severe.
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all calibration 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.
Beckman Coulter is recalling 2,146 units of SYNCHRON Systems Phosphorus reagent because specific lots may fail calibration before the lot expiration date, delaying patient results.
VITROS Chemistry Products LAC Slides from coating 0130 and above are recalled because of increased calibration failures on VITROS XT systems, delaying lactate results. 2,908 units are affected.
VITROS Chemistry Products LAC Slides, catalog 8150112, from coating 0130 and above are recalled because of increased calibration failures on VITROS XT systems, delaying lactate results. 2,320 units are affected.
VITROS Chemistry Products Ca Slides, catalog number 145 0261, generations 67 and above, are recalled because calibration failures on VITROS XT systems delay calcium test results. 174,215 units are affected.
Beckman Coulter is recalling the DxC 500 AU Clinical Chemistry Analyzer due to a software error that prevents the analyzer from completing calibration orders under certain conditions, which can delay test result reporting.
Beckman Coulter Inc. is recalling specific lots of Access PCT Reagent Pack due to high rates of calibration failures that delay test result reporting on immunoassay systems used in healthcare and laboratory settings.
DRG International is recalling the DRG:HYBRiD-XL Insulin device (Model HYE-5361) due to calibration failures and out-of-specification controls that may delay assay results.
Roche's cobas HCYS homocysteine test assay is recalled due to calibration defects that can produce inaccurate results. The assay can yield false positive or negative values.
Smiths Medical ASD is recalling medex Arterial Kits due to a manufacturing defect in the TranStar Disposable Pressure Transducer that may cause inaccurate readings or device failure.
Smiths Medical is recalling the medex TranStar Stopcock due to a manufacturing defect that can cause inaccurate pressure monitoring, interrupted pressure monitoring, or inability to zero the device.
Smiths Medical is recalling approximately 3,280 medex TranStar KIDS KIT blood sample devices due to a manufacturing defect causing pressure monitoring failures.
Smiths Medical recalls the medex TranStar KIDS KIT blood sample kit due to manufacturing defects in the pressure transducer that may cause inaccurate or interrupted pressure monitoring, or prevent proper device calibration.
Ortho-Clinical Diagnostics is recalling VITROS Vitamin B12 Range Verifier Lot 1200 because the product may fail to verify required calibration range. The failure is detectable during use and does not affect actual patient test results.
Ortho-Clinical Diagnostics is recalling VITROS Immunodiagnostic Products used to test for Hepatitis B antibodies due to potential calibration failures and falsely elevated test results affecting specific lot numbers.
Beckman Coulter's Transferrin reagent lot 2573 does not maintain stability as claimed, causing unreliable patient test results and control failures. The company confirmed the issue affects diagnostic accuracy.
RR Mechatronics Starrsed Control Level N ESR vials were mislabeled as a different control level, causing instruments to flag results as out of range. The mislabeling affects approximately 9,306 units worldwide.
Philips is recalling 1,421 EarlyVue VS30 Vital Signs Monitor units in the U.S. because a missing calibration alarm can cause inaccurate CO2 measurements and failure to detect critical patient condition changes.
Ortho-Clinical Diagnostics is recalling 132 units of VITROS Chemistry Calibrator Kit 11 with defective Assay Data Disk versions due to inability to calibrate vancomycin reagent, delaying laboratory testing.
Beckman Coulter is recalling Bicarbonate reagent (REF: OSR6137) worldwide due to potential decreases in calibration optical densities that could cause calibration and quality control failures in clinical laboratory tests.
Beckman Coulter has recalled Bicarbonate reagent used in laboratory testing due to a potential decrease in calibration readings. The issue could result in calibration and quality control failures.
Beckman Coulter is recalling Bicarbonate reagent (REF: OS6637) due to potential calibration failures. The reagent could produce decreased optical density readings affecting laboratory quality control.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Calibrator Kit 9 due to incorrect calibration software (DRVs 6194-6200) that prevents laboratory systems from successfully calibrating, causing delayed test results.
Randox Cholesterol diagnostic kits fail to meet stated performance specifications. Calibration issues cause quality control results to fall outside acceptable ranges, potentially delaying test results.
Ortho-Clinical Diagnostics is recalling VITROS Immunodiagnostic Products LH Reagent Pack due to low-end imprecision that may produce falsely high or delayed patient and quality control results.
Specific lots of VITROS FSH, LH, and Prolactin reagent kits may produce falsely high or delayed test results at low measurement levels. Affected lots distributed worldwide; labs should discontinue use and contact the manufacturer.