BD COR System Software. Model Number: 444829.
This recall is currently active, issued July 23, 2025. It was issued by Becton Dickinson & Co..
- Company
- Becton Dickinson & Co.
- Recall Initiated
- June 23, 2025
- Posted
- July 23, 2025
- Recall Number
- Z-2162-2025
- Quantity
- 7 systems
- Firm Location
- Sparks, MD
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.
Distribution
Worldwide - US Nationwide distribution in the states of Florida, Texas and Michigan. The countries of Sweden and Belgium.
Lot / Code Info
Model Number: 444829. UDI-DI: 00382904448295. Software version 8.80 and above.
Root Cause
Under Investigation by firm
Action Taken
Becton, Dickinson and Company began notification of consignees on about 06/23/2025 via telephone call and followed by a letter. Consignees were instructed to note the outlined workflows when loading specimens with the Over labeling feature enabled and consider retesting affected specimens for HPV testing if affected. Consignees were also instructed to post the notification within their facility, notify customers if affected units were further distributed, and complete and return the provided Customer Response Form.