Hazard
16 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 16 invalid 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 invalid 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.
Hologic is recalling one master lot of the Aptima HPV Assay because the product exhibits potential to generate either invalid or false negative results.
Abbott is recalling one lot of the ID NOW Influenza A & B 2 test after confirming the lot has a higher occurrence of invalid rates than stated in the Instructions for Use.
Abbott Diagnostics is recalling certain lots of the ID NOW COVID-19 2.0 24T test device due to higher-than-expected rates of invalid test results. The affected devices were distributed nationwide.
Abbott is recalling certain lots of the ID NOW COVID-19 2.0 24T test device due to higher invalid result rates than stated in product instructions. The affected lots were distributed worldwide.
Hologic Rapid fFN Specimen Collection Tubes from three lots may contain incorrect amounts of extraction buffer, potentially causing invalid test results or diagnostic errors in preterm delivery assessment.
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.
Cepheid is recalling 1,413 Xpert Xpress Strep A test kits due to a defect in the included pipettes. Defective pipettes may fail to dispense adequate sample volume, resulting in invalid test results or no test result.
DiaSorin is recalling 4,142 Simplexa Flu A/B & RSV Direct Gen II diagnostic kits due to leaking Direct amplification Discs that may cause contamination, cross-contamination, invalid test results, and system error codes.
Roche Molecular Systems recalls the cobas 5800 PCR testing instrument due to false positive and invalid results caused by anomalous baselines. This may lead to erroneous or delayed diagnoses.
Hologic is recalling 1,355 Panther Fusion Tube Trays because they may leak, potentially causing false positive, false negative, or invalid patient results.
Roche is recalling cobas z 480 analyzers because a dirty lens may cause invalid or false positive results.
Roche Diagnostics is recalling Albumin Gen.2 reagents due to cross-contamination causing low quality recovery and invalid calibrations.
bioMerieux is recalling NUCLISENS Lysis Buffer, Lot 19040201, because pH electrode dysfunction caused colored eluates and invalid test results.
T2 Biosystems is recalling T2Candida Cartridges because they produced elevated levels of invalid results. The recall affects 6,864 units distributed to 17 states.
Focus Diagnostics is recalling 38 Anaplasma phagocytophilum IFA IgM Test Kits due to a potential increase in invalid results.
Roche Molecular Systems is recalling cobas 4800 KRAS Mutation Test kits because they are generating invalid results for the Mutant Control and/or KRAS Calibrator.