Hazard
35 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 35 false 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 0 (0%) are Severe.
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all false 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.
Changchun Wancheng Bio-Electron is recalling 1,000 units of the S. Typhi/Para Typhi A Antigen test because it was distributed before it could be legally marketed.
Changchun Wancheng Bio-Electron is recalling 1,000 units covering the Male Fertility Sperm Test for Home Use (Cassette) because tests requiring a 510(k) were distributed before they could be legally marketed.
Changchun Wancheng Bio-Electron is recalling 1,000 units of the Menopause Test Cassette (Urine) because tests requiring a 510(k) were distributed before they could be legally marketed.
Changchun Wancheng Bio-Electron is recalling 91,366 units of LotFancy Urinary Tract Infection Urine (UTI) Test Strips because tests requiring a 510(k) were distributed before they could be legally marketed.
Changchun Wancheng Bio-Electron is recalling 1,000 units of the LH One Step Ovulation Test Device (Urine) because tests requiring a 510(k) were distributed before they could be legally marketed.
Changchun Wancheng Bio-Electron is recalling 4,800 units of the Exploro Highly Sensitive Male Fertility / Sperm Concentration Test because tests requiring a 510(k) were distributed before they could be legally marketed.
Changchun Wancheng Bio-Electron is recalling 500 units of the Vivoo pH Test because tests requiring a 510(k) were distributed before they could be legally marketed.
Changchun Wancheng Bio-Electron is recalling 500 units of the Vivoo Protein Test because tests requiring a 510(k) were distributed before they could be legally marketed.
Changchun Wancheng Bio-Electron is recalling 32,500 units covering The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips because tests requiring a 510(k) were distributed before they could be legally marketed.
Changchun Wancheng Bio-Electron is recalling 3,300 units of Vivoo Sodium Test because tests requiring a 510(k) were distributed before they could be legally marketed.
Changchun Wancheng Bio-Electron is recalling 3,000 units of Vivoo Vaginal pH Test because tests requiring a 510(k) were distributed before they could be legally marketed.
Agilent's GenetiSure Dx Labeling Kit contains a human reference DNA component with a mosaic aberration that may cause false test results and diagnosis delays in genetic testing.
Sysmex PS-10 Sample Preparation Systems may produce false test results due to sporadic omission of the probe wash step during antibody pipetting. Thirty-two units have been recalled nationwide.
Beckman Coulter is recalling over 465,000 thyroglobulin antibody test kits because their instructions incorrectly state that biotin interference was addressed. The false information could lead to false-low test results.
Beckman Coulter has recalled 13,565 units of IGM clinical reagent due to incorrect lipemia check settings that may produce false low results or report high results as normal. Affected units were distributed worldwide.
Siemens Atellica CH and CI analyzers may produce falsely elevated cholesterol and lipid test results (2–16% high) after iron tests. This affects clinical calibration, quality control checks, and patient test results.
The EliA GliadinDP IgG test well produces higher reported results when used on the Phadia 2500EE instrument compared to the Phadia 250, potentially causing diagnostic inaccuracies. Phadia US Inc is recalling 568 units distributed in California, New Jersey, and Michigan.
The Instructions for Use for BD Veritor System rapid diagnostic tests for COVID-19 and flu were not FDA-approved, lacking proper specimen type specifications. Using the test with invalid specimen types could produce false positive or negative results, potentially delaying diagnosis or treatment.
Siemens Healthcare is recalling IMMULITE 2000 hCG diagnostic systems due to potential sample carryover that could produce falsely elevated hCG test results.
Meridian Bioscience is recalling Revogene diagnostic devices due to compromised photomultiplier tubes that may produce false-positive or indeterminate test results.
Thermo Fisher Scientific is recalling 19 Cascadion Clinical Analyzers because a software defect may cause false Vitamin D deficiency results.
Ansh Labs is recalling 327 SARS-CoV-2 IgM ELISA kits to update instructions and reduce the risk of false test results.
Beckman Coulter is recalling ISE Electrolyte Reference Reagent because low pH levels may cause calibration failures and false high patient results, potentially delaying treatment.
The Binding Site Group is recalling OPTILITE IgM Kits due to potential calibration difficulties that may cause false patient results and testing delays.
Biomerieux Inc is recalling 738 VIDAS 3 immunoanalyzers because a software defect may allow expired calibrations to be used without warning, potentially causing false test results.