Lower riskMedical device recall · FDA · Published June 23, 2025
BD COR System Software Recall: False Negative Results Risk
Becton Dickinson recalls software version 8.80+ for BD COR System Model 444829 due to potential false negative results. Affected users should contact for remedy.
“BD COR System Software Recall: False Negative Results Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51981-bd-cor-system-software-recall-false-negative-results-risk. Based on FDA recall #Z-2162-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2162-2025%22&limit=1).
Becton Dickinson & Co. voluntarily recalled BD COR System Software, model number 444829, due to a potential functionality issue that could cause false negative results, the FDA announced on June 23, 2025. The recall affects software version 8.80 and above distributed worldwide.
How to tell if you have it
Brand: Becton Dickinson
Product: BD COR System Software
Model Number: 444829
UDI-DI: 00382904448295
Software version: 8.80 and above
The hazard
The recall addresses a potential functionality issue supporting the Over labeling feature that could lead to possible false negative results. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Becton Dickinson & Co. has had 43 other recalls on record since June 1, 2017. Other recent recalls of similar products include Meridian Bioscience Revogene C. difficile Test Recall (Dec. 5, 2025) and Beckman Coulter DxC 500i Modules with Software 1.5 Risk (July 15, 2026).
How to tell if you have this one
Check for software version 8.80 or higher on the BD COR System with model number 444829. The UDI-DI code 00382904448295 is also associated with this recall.
Brand
Becton Dickinson
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your BD COR System software version is 8.80 or higher with model number 444829.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 3 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide distribution in the states of Florida, Texas and Michigan. The countries of Sweden and Belgium.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Michigan, Texas.
Recall timeline
FDA published this recall 37 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2162-2025 (June 23, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2162-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.