FDA Medical Device Recalls (openFDA)
Becton Dickinson & Co.: BD COR System Software. Model Number: 444829.
- Recall number
- Z-2162-2025
- Recalling firm
- Becton Dickinson & Co.
- Product
- BD COR System Software. Model Number: 444829.
- Status
- Open, Classified
- Initiated
- 2025-06-23
- Posted
- 2025-07-23
- Terminated
- not on file
- Reason
- Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 7 systems
- Distribution
- Worldwide - US Nationwide distribution in the states of Florida, Texas and Michigan. The countries of Sweden and Belgium.
- Lot, serial or model codes
- Model Number: 444829. UDI-DI: 00382904448295. Software version 8.80 and above.
- 510(k) numbers
- not on file
- PMA numbers
- ["P160037"]
- Product code
- MAQ
- Firm FEI
- 1119779
- Firm city
- Sparks
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28