BD COR System Software. Model Number: 444829.
Pending LLM rewrite. Source: FDA_DEVICE Z-2162-2025.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.
The recalled product
- Product
- BD COR System Software. Model Number: 444829.
- Manufacturer
- Becton Dickinson & Co.
- Category
- Medical Device — Devices
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.
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