FDAHealthJune 23, 2025
Becton Dickinson & Co. — BD COR System Software. Model Number: 444829.
⚠️ Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 23, 2025
Worldwide - US Nationwide distribution in the states of Florida, Texas and Michigan. The countries of Sweden and Belgium.
What's affected?
- Product
- BD COR System Software. Model Number: 444829.
- Lot code
- Model Number: 444829. UDI-DI: 00382904448295. Software version 8.80 and above.
Additional details
Model Number: 444829. UDI-DI: 00382904448295. Software version 8.80 and above.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 7 systems.
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