Z-2162-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 30, 2025
- Initiation Date
- June 23, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 systems
Product Description
BD COR System Software. Model Number: 444829.
Reason for Recall
Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of Florida, Texas and Michigan. The countries of Sweden and Belgium.
Code Information
Model Number: 444829. UDI-DI: 00382904448295. Software version 8.80 and above.