Hazard
42 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 42 diagnostic 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 1 (2%) are Severe.
Which agencies issued them
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all diagnostic 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.
Philips is recalling 611 MR 5300 MRI scanners due to a software issue that can terminate examinations during image reconstruction if system memory is exceeded.
Remel, Inc is recalling GC Agar Base culture media because some strains of Neisseria gonorrhoeae may not be recovered or may show reduced recovery on the product.
Luminex is recalling VERIGENE Gram Negative Blood Culture test cartridges due to a consumable issue that may produce incorrect results on a small portion of one lot.
GM is recalling certain 2020-2022 Bolt EV and 2022 Bolt EUV vehicles previously remedied under 21V-650, because diagnostic software may have been installed incorrectly and fail to detect defective battery modules.
Becton Dickinson is recalling 2,061 kits of BD SARS-CoV-2 Reagents for BD MAX Systems because they may produce false negative results due to decreased enzyme activity. The kits were distributed nationwide and internationally.
Becton Dickinson recalls BD Phoenix Yeast ID Panel units (Lot 3312180) due to misplaced esculin substrate that triggers system abortion. No injuries reported.
The disk bay component in certain Philips Azurion x-ray systems may fail, potentially preventing diagnostic imaging and delaying procedures. Affected units have been distributed worldwide.
Canon Medical's INFX-8000F X-ray system may display abnormal horizontal stripe patterns due to a manufacturing change in the flat panel detector's internal board, potentially preventing exam completion.
BD BBL Sensi Disc Imipenem susceptibility test discs may fail to accurately assess antibiotic resistance. This could delay diagnosis or lead to inappropriate antibiotic treatment selection.
Medline Industries is recalling certain blood culture kits due to a Bactec component with an expiration date not reflected on the kit insert. Users may unknowingly use an expired component if they do not check the Bactec itself.
One lot of Remel Todd Hewitt Broth culture medium may fail to recover Group B Streptococci during testing or use with patient samples, potentially resulting in missed diagnoses.
Qiagen's QIAstat-Dx Respiratory SARS-CoV-2 Panel may fail to produce diagnostic results due to software errors in affected cartridges. Test runs will abort with error codes, leaving no test results available.
Cytocell Ltd. RET Proximal Probe kits distributed to laboratories in California, Florida, Ohio, and South Carolina are being recalled due to inverted DNA sequences introduced during manufacturing.
Remel is recalling specific lot numbers of Haemophilus Test Medium (Agar) because the test medium may not perform as intended. This diagnostic device is used in laboratory testing nationwide.
Roche Molecular Systems recalls cobas SARS-CoV-2 & Influenza A/B assay kits used in clinical laboratories. The kits may produce false negative Influenza A results, potentially delaying accurate diagnosis.
Biomerieux is recalling ETEST Meropenem diagnostic tests because units experienced temperature and time storage excursions that may affect test accuracy. Affected lot 1009462290 was distributed nationwide.
Detect Headquarters is recalling specific lots of Detect COVID-19 Test (Model 21205) due to risk of false negative results. Affected tests may fail to detect COVID-19 infection, potentially delaying treatment and increasing community spread.
Biomerieux Inc. is recalling PPM CLINICAL CHROMID STREPTO B diagnostic media (batch 1009534170) because storage temperature and time exceeded specified limits, preventing assurance of product performance.
Biomerieux is recalling VITEK 2 AST-GN70 test kits nationwide due to temperature and time excursions that may compromise test performance and diagnostic reliability.
Biomerieux recalls VIDAS Listeria 60T test kits (Batch 1009371140) distributed nationwide because storage conditions were exceeded and product performance cannot be guaranteed. Users should discontinue use and contact the manufacturer.
Biomerieux Inc is recalling PPM CLINICAL CHROMID MRSA 20 PLT diagnostic culture media (84 units) due to temperature and time exceedance during storage that may compromise product performance.
Biomerieux Inc is recalling CHROMID CARBA laboratory products nationwide because storage conditions exceeded acceptable temperature and time ranges. The company cannot guarantee product performance.
Siemens Healthcare Diagnostics recalls N Antiserum to Human IgG reagent for laboratory analyzers because it does not meet expected High-Dose Hook Effect performance specifications for IgG measurements in certain sample types.
Surpria 64 CT scanner software versions V3.11 and V3.22 may encounter errors that prevent image reconstruction, requiring repeat scans that expose patients to additional radiation. 16 units nationwide are affected.
Aggredyne, Inc. is recalling the AggreGuide A-100 Instrument due to a software design defect that causes the device to run assays at 0 RPM, resulting in no blood mixing and inaccurate test results displayed as Low.