Device product
BD COR System Software. Model Number: 444829.
Z-2162-2025
Product summary
- Event
- Event 97142
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7 systems
- Official record key
device-enforcement:Z-2162-2025
Official wording
Reason: Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.
Code information: Model Number: 444829. UDI-DI: 00382904448295. Software version 8.80 and above.
Distribution pattern: Worldwide - US Nationwide distribution in the states of Florida, Texas and Michigan. The countries of Sweden and Belgium.
Derived failure modes
-
Unknown
Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.