Becton Dickinson & Co. recalls BD COR System Software. Model Number: 444829.

Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.

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.

• FDA enforcement recordOfficial FDA database entry for Z-2162-2025
• FDA device classification · MAQOfficial FDA classification for this device type
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Becton Dickinson & Co.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.