Hazard
55 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 55 test inaccuracy 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 (2%) are Severe.
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all test inaccuracy 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.
Chromsystems is recalling MassCheck Amino Acid Acylcarnitines dried blood spot control material due to too-low glycine concentration in batch 2821. The defect was found in units distributed to New York, Ohio, and Connecticut.
Becton Dickinson is recalling 199 units of BD Anti-Kappa PE flow cytometry reagent because samples may exhibit uncharacteristic flow profiles that could affect test accuracy.
Bio-Rad Laboratories recalls the BioPlex 2200 ToRC IgM Reagent Pack (Lot 301388) due to CMV IgM analyte showing variable elevated background levels depending on reagent handling.
Cytocell Ltd. is recalling TCL1 Breakapart FISH probes (Lot 074612) because the diagnostic test may show unexpected signals beyond the intended chromosome target.
Bio-Rad Laboratories is recalling 724 BioPlex 2200 Syphilis Calibrator sets due to COVID-19 vaccine interference concerns and manufacturing problems with reagent stability. The recalled lots were distributed nationwide in the U.S. and internationally.
Microbiologics Inc recalls KWIK-STIK AST-GP quality control materials that produce incorrect antibiotic susceptibility test results. Two lot numbers were distributed worldwide.
Siemens Healthcare Diagnostics is recalling Atellica IM 1600 analyzers that may leak reagent when located at altitudes above 350 meters, potentially causing testing errors.
Abbott's A-ALT diagnostic reagent may produce inaccurate test results for samples with elevated enzyme or bilirubin levels, potentially affecting patient outcomes. The affected reagent kits have been distributed worldwide.
Luminex Corporation is recalling 1,261 Verigene Clostridium difficile test kits due to potential for false-negative results. The kits may fail to detect C. difficile infections, potentially delaying diagnosis.
The LeadCare II Blood Lead Test Kit may generate artificially low control test results, causing blood lead levels to be underestimated in patient samples. Kits were distributed worldwide.
Remel Inc is recalling 408 units of Haemophilus Test Medium because lighter-than-normal growth may make antimicrobial test zones difficult to measure.
Remel Inc is recalling 19 units of Haemophilus Test Medium because lighter-than-normal growth may make antimicrobial test zones difficult to measure.
Abbott Point Of Care Inc. is recalling i-STAT EG7+ cartridges because the ionized calcium test may report higher than expected results if stored at room temperature for specific periods.
Roche Diagnostics is recalling Lactate Gen.2 reagents because new endogenous interference claims may affect test accuracy on specific analyzers.
Roche Diagnostics is recalling 774 units of Albumin BCP reagent due to calibration failures and QC imprecision caused by elevated pH levels.
Tosoh Bioscience Inc is recalling AIA-PACK B12 reagents because fluorescein interference may cause inaccurately elevated Vitamin B12 test results.
Ortho Clinical Diagnostics is recalling VITROS FSH Reagent Packs because biotin supplements may cause biased test results at lower concentrations than indicated.
bioMerieux is recalling VITEK 2 AST-P640 cards because some lots contain insufficient gentamicin, potentially affecting high-level resistance test results.
Diagnostica Stago is recalling STA N¿oplastine¿ CI in-vitro diagnostic kits because quality control values fell outside assigned ranges, potentially affecting prothrombin time test results.
Ortho-Clinical Diagnostics is recalling 349 units of VITROS DAT Performance Verifier I because the storage labeling is incorrect, which may cause lower than expected test results.
Euro Diagnostica is recalling 1,090 units of DIASTAT ANA ELISA kits because high background levels may cause false positive test results.
BioMerieux SA is recalling 911 units of NucliSENS Lysis Buffer because residual heme may inhibit PCR reactions, leading to uninterpretable test results.
Siemens is recalling Dimension Vista 500 and 1500 lab systems because ECREA test results may be falsely elevated in isolated cases.
Randox Laboratories is recalling 15 units of Magnesium IVD reagents for the RX Imola analyser due to carryover interference from amylase tests.
Ameditech is recalling ProScreen 6 Panel Dip Drug Screen kits due to reduced reactivity for two specific benzodiazepine compounds.