Hazard
29 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 29 test 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 test 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.
WALLAC OY is recalling GSP Neonatal GALT Kit units due to reduced on-board stability that may increase run-QC failures and delay patient test results.
BioFire Diagnostics, LLC is recalling the Spotfire Respiratory/Sore Throat Panel due to false negative test results and control failures that may not accurately detect infections.
VITROS XT 7600 Integrated System software may not warn users when Signal Reagent Packs expire, risking inaccurate or missing test results.
Biocare Medical is recalling specific IHC kits containing DAB Buffer because they may produce weak or no staining, leading to test failure.
Cepheid is recalling Xpert Xpress Strep A test kits because pipettes may fail to dispense adequate sample volume, potentially resulting in invalid or absent test results.
Qiagen's QIAstat-Dx Respiratory SARS-CoV-2 Panel diagnostic kits are recalled due to decreased performance reliability. Failed test runs could require sample retesting, potentially delaying diagnosis.
Qiagen has recalled 4155 QIAstat-Dx Respiratory SARS-CoV-2 Panel kits due to decreased performance reliability. Test failures (run abortions) may require samples to be retested, potentially delaying diagnosis.
Quidel is recalling specific lots of MicroVue C1-Inhibitor Plus EIA test kits that may produce low optical density values and invalid test results.
Biomerieux Inc is recalling PPM Clinical Chromid Candida diagnostic plates because storage temperature and time parameters were exceeded, preventing performance guarantees.
A. MENARINI diagnostics hemoglobin A1c control materials (Lot 12161) are producing incorrect results that cause analyzer errors and prevent diagnostic testing. Facilities using this lot should discontinue use and contact the manufacturer.
Oxford Immunotec recalled 81 T-SPOT.TB diagnostic test kits (Lot TEC4000098) due to storage equipment failure that kept products outside the validated 2-8°C temperature range. The excursion may affect test accuracy.
bioMerieux recalls NUCLISENS easyMAG Magnetic Silica reagent kits due to contamination that may cause test failures or delayed results. Affected kits were distributed across 23 U.S. states.
Luminex Corporation is recalling a lot of VERIGENE Nucleic Acid Test Kit extraction trays due to missing reagent causing increased internal control failures. Affected lot: 101321021B, 984 units distributed in the US.
bioMerieux is recalling two lots of VIDAS SARS-COV-2 IgG diagnostic tests due to substrate errors that prevent test execution, requiring users to repeat testing and potentially delaying results.
bioMerieux is recalling one lot of VIDAS Estradiol II diagnostic test devices due to a substrate error that prevents tests from running, causing delayed results and requiring repeat testing.
bioMerieux is recalling VIDAS Measles IgG test kits due to a substrate error that prevents the test from running, requiring users to repeat testing and potentially delaying results.
bioMerieux recalls VIDAS Clostridium Difficile GDH diagnostic test kits due to a substrate error that prevents test execution. Affected users must retest samples, potentially delaying results.
bioMerieux is recalling one lot of VIDAS Mumps IgG diagnostic tests because a substrate error prevents the tests from running, causing delays.
bioMerieux is recalling 1,579 VIDAS DEX@ diagnostic devices due to substrate errors that prevent test execution, requiring users to rerun tests and potentially delaying results.
bioMerieux is recalling 1,818 units of VIDAS PRG Progesterone test kits due to a substrate error that prevents the tests from running properly, causing delayed results when patients need repeat testing.
bioMerieux is recalling three lots of VIDAS RUB IgG test kits due to substrate errors that prevent the test from running, potentially delaying diagnostic results.
bioMerieux is recalling one lot of VIDAS SARS-CoV-2 IgM tests nationwide due to a substrate defect that prevents the test from running. The defect causes delayed results as users must repeat testing.
bioMerieux VIDAS LH test kits (lot 1008848600) are affected by a substrate error that prevents test execution, requiring users to repeat testing and potentially delaying results.
bioMerieux is recalling three lots of VIDAS Lyme IgM II diagnostic test kits due to a substrate error that prevents the test from running, requiring users to conduct another test to obtain results.
Qiagen is recalling 298 EZ1 Advanced XL instruments due to a power board defect that may cause heater malfunctions and compromise nucleic acid extractions.