Hazard
16 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 16 incorrect test results recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (6%) are Severe.
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all incorrect test 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.
Siemens Healthcare Diagnostics is recalling 3,266 units of ADVIA 120/2120/2120i 3-in-1 TESTpoint Control worldwide due to incorrect platelet value assignments that could affect test results.
Abbott is recalling certain myoglobin test kits because of manufacturing defects that could lead to incorrect results and delayed heart attack diagnosis.
A software defect in VITROS XT 7600 diagnostic systems running version 3.8.1 causes quality control baseline statistics to fail to update properly, potentially resulting in erroneous patient laboratory results.
RX Imola-IVD Clinical Chemistry Analyzers may report test results incorrectly when handling out-of-range samples due to improper parameter rerun settings. 35 units nationwide are affected.
The RX Daytona Plus clinical chemistry analyzer may report incorrect results when samples fall outside normal range and the automatic rerun feature malfunctions. Randox Laboratories is recalling 5 units distributed nationwide.
Randox Laboratories is recalling the RX Modena-IVD Clinical Chemistry Analyzer nationwide due to parameter re-run settings that may fail to function correctly when samples are outside the assay range, potentially resulting in incorrect test results.
A firmware bug in Inpeco laboratory automation modules may cause sample misidentification, leading to incorrect electrolyte test results and potential treatment errors.
Roche is recalling approximately 965 cobas e801 Immunoassay Analyzers nationwide due to a software issue that impacts Pre-Wash test signals and results for six diagnostic assays. No injuries or illnesses have been reported.
Accriva Diagnostics distributed an unclearred variant of the VerifyNow P2Y12 platelet test that displays different results than the FDA-cleared device. A correction formula has been provided to healthcare providers.
bioMerieux VITEK 2 bacterial identification systems have a software defect where antibiotic susceptibility and synergy test results transmitted to laboratory systems may omit user or automated corrections, potentially leading to incorrect test interpretation.
Diagnostic control microorganisms manufactured by Microbiologics Inc are recalled for returning incorrect antibiotic susceptibility test results. These controls failed quality specifications and could cause inaccurate lab test results.
Microbiologics Inc is recalling KWIK-STIK quality control kits used by laboratories because certain lots return incorrect test results that could affect laboratory testing accuracy.
Inpeco's automation interface module firmware may incorrectly associate laboratory test results with patient sample IDs, potentially causing incorrect patient results.
Abbott's Alinity ci-series analyzers with software version 3.2.3 and earlier have multiple issues that could display expired reagents as valid, fail to alert operators to errors, and produce incorrect test results.
Abbott Laboratories is recalling its Alinity c Activated Alanine Aminotransferase reagent kit due to potential analytical errors that could produce incorrect test results. The issue affects certain lot numbers distributed worldwide.
Remel Inc is recalling specific lots of Gentamicin Antimicrobial Susceptibility Testing Discs because the antibiotic concentration may be insufficient, potentially leading to incorrect test results.