BD COR System Software Potential False Negative Results in Diagnostic Testing
BD COR System Software has a potential functionality issue with the Over labeling feature that could produce false negative results. The 7 affected systems are distributed in Florida, Texas, Michigan, Sweden, and Belgium.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for diagnostic software with a potential functionality issue that could produce false negative results. No illnesses or injuries have been reported, placing this in the High category as a risk-of-harm product without documented injury.
Plain-English summary
Becton Dickinson & Co. is recalling BD COR System Software, Model Number 444829 (Software version 8.80 and above). The recall affects 7 systems worldwide.
The software contains a potential functionality issue related to the Over labeling feature that could lead to false negative results. This means affected systems may produce incorrect negative results in diagnostic testing.
The affected systems have been distributed globally, including in the United States (Florida, Texas, and Michigan), Sweden, and Belgium.
The recall notice does not specify recommended user actions. Healthcare facilities using the affected systems should contact Becton Dickinson & Co. for guidance on managing this potential functionality issue.
The recalled product
- Product
- BD COR System Software. Model Number: 444829.
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- false-negative-results
- software-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model Number: 444829. UDI-DI: 00382904448295. Software version 8.80 and above.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03