BD COR System Software (Becton Dickinson) – Functionality Issue (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BD COR System Software. Model Number: 444829.
Brand
Becton Dickinson & Co.
Lot Codes / Batch Numbers
Model Number: 444829. UDI-DI: 00382904448295. Software version 8.80 and above.
Products Sold
Model Number: 444829. UDI-DI: 00382904448295. Software version 8.80 and above.
Becton Dickinson & Co. is recalling BD COR System Software. Model Number: 444829. due to Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026