Recall Z-2162-2025 ยท MAQ Kit, Dna Detection, Human Papillomavirus
Becton Dickinson & Co.
BD COR System Software. Model Number: 444829.
| Date | Jul 23, 2025 (initiated Jun 23, 2025) |
| Status | Open, Classified |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.