—#214649

Product

BD COR System Software. Model Number: 444829.

FDA product code: MAQ — Kit, Dna Detection, Human Papillomavirus
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P160037
Affected lot / code info: Model Number: 444829. UDI-DI: 00382904448295. Software version 8.80 and above.

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Becton Dickinson & Co.
Address: 7 Loveton Cir, Sparks, Maryland 21152-9212

Distribution

Distribution pattern: Worldwide - US Nationwide distribution in the states of Florida, Texas and Michigan. The countries of Sweden and Belgium.

Timeline

Recall initiated: 2025-06-23
Posted by FDA: 2025-07-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #214649. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.