Recall Z-2162-2025
Becton Dickinson & Co. · initiated June 23, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
BD COR System Software. Model Number: 444829.
Codes / lots: Model Number: 444829. UDI-DI: 00382904448295. Software version 8.80 and above.
Reason for recall
Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.
FDA-determined 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.
Details
- Recall number
- Z-2162-2025
- Initiated
- June 23, 2025
- Posted by FDA
- July 23, 2025
- Product code
- MAQ – Kit, Dna Detection, Human Papillomavirus
- Quantity
- 7 systems
- Distribution
- Worldwide - US Nationwide distribution in the states of Florida, Texas and Michigan. The countries of Sweden and Belgium.
- Recalling firm
- Becton Dickinson & Co., Sparks, MD