Hazard
147 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 147 erroneous results recalls we have scored against our rubric, 1 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (3%) are Severe.
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all erroneous results 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.
A software defect in VITROS 4600 Chemistry Systems causes quality control baselines to not update when users change them, potentially causing erroneous patient results.
A software defect in VITROS 5600 Systems prevents quality control baseline statistics from updating properly, which may cause erroneous patient test results to be reported.
Ortho-Clinical Diagnostics is recalling VITROS 5600 diagnostic systems (software versions 3.8.0 or 3.8.1) due to a defect that prevents quality control alerts from displaying, potentially allowing erroneous patient test results to be reported.
Ortho-Clinical Diagnostics is recalling VITROS immunodiagnostic analyzer systems that may aspirate unintended sample containers during processing, potentially causing erroneous test results.
Beckman Coulter DxI 9000 immunoassay analyzers may produce erroneous lab results due to software bugs affecting unit conversion and result calculation. Affected devices use software version 1.16 or earlier; 128 devices worldwide are impacted.
Beckman Coulter recalled the REV 2 Flowcell Capsule Spare due to potential rust in the cannula component, which could generate erroneous test results.
Beckman Coulter is recalling DxU 850m/840m Microscopy Analyzers (254 units) due to potential rust in the cannula component, which may cause erroneous test results. The recall affects units distributed in the US and multiple international locations.
Beckman Coulter is recalling 112 units of iQ200 Series Urine Microscopy Analyzers distributed globally. The cannula in the Flowcell and Rinse Waste Well Assembly may rust, potentially causing erroneous diagnostic results.
Abbott Laboratories is recalling 8,424 Alinity ci-series System Control Module units due to software performance issues that could produce erroneous test results. Affected systems are used in clinical laboratories throughout the United States and 90+ countries.
Siemens epoc NXS blood analysis systems have a software defect causing incorrect test results to be printed or transmitted. Results may include data from previous patients, potentially leading to misdiagnosis.
Nova Biomedical's Stat Profile Prime Plus POC analyzer may report inaccurate creatinine results during the first 2-4 hours after sensor cartridge installation. Standard quality control checks may not detect these errors.
Beckman Coulter is recalling approximately 4,100 laboratory immunoassay analyzers due to defective nut bands that may cause operational failures and erroneous patient test results.
Siemens Dimension Magnesium Flex reagent cartridges may produce inaccurate test results without triggering warning flags. Some results may show magnesium levels 15–59% lower than actual values.
Siemens recalled 2,321 Atellica IM 1600 Analyzers due to incompatibility with Test Definition Version 1.4, which may produce erroneous total T3 test results. Worldwide distribution affected.
Siemens is recalling 1,566 Atellica IM 1300 Analyzers distributed worldwide because certain lots are incompatible with Test Definition version 1.4 and may generate incorrect total T3 thyroid test results.
Stanbio Laboratory's Creamatocrit Plus breast milk analyzer was marketed without required FDA 510(k) clearance. Its performance has not been validated, and erroneous results could lead to inadequate nutritional supplementation for infants.
Beckman Coulter is recalling 1,433 units of a cholesterol reagent that may fail calibration and produce erroneous low test results. Affected units were distributed nationwide and internationally.
The FDA is recalling Kaluza C Flow Cytometry Software versions 1.0, 1.1.1, and 1.1.2 due to software anomalies that may generate erroneous results affecting diagnostic interpretation.
Normand Remisol Advance Data Manager versions 1.5–1.9 have insufficient instructions for proper rule programming and testing. User-written rules may not be properly validated, potentially leading to erroneous laboratory results.
Siemens Healthcare Diagnostics is recalling Dimension Vista HDLC reagent cartridges due to discolored reagents that may cause erroneous test results.
Inpeco S.A. is recalling 104 Aptio Automation Systems with Aliquoter Modules because a software error may cause samples to be diluted with water, leading to erroneous test results.
Inpeco S.A. is recalling 136 Accelerator a3600 Automation Systems with Aliquoter Modules due to a software error that may dilute samples with water, leading to erroneous test results.
Inpeco S.A. is recalling 93 FlexLab Automation Systems with Aliquoter Modules because a software error may cause samples to be diluted with water, leading to erroneous test results.
Beckman Coulter is recalling 219 units of UIBC reagent lot 2690 because it produces erroneously high patient results at the low end of the linear range.
Randox Laboratories is recalling Lactate Dehydrogenase P-L reagent to address reagent carryover issues on RX instruments that may cause erroneous test results.