BD COR System Software. Model Number: 444829.
FDA device recall Z-2162-2025 · posted 2025-07-23 · Open, Classified
Recall details
- Recalling firm
- Becton Dickinson & Co.
- Reason for recall
- Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- MAQ
- Quantity affected
- 7 systems
- Distribution
- Worldwide - US Nationwide distribution in the states of Florida, Texas and Michigan. The countries of Sweden and Belgium.
- Date initiated
- 2025-06-23
- Date posted
- 2025-07-23
- Location
- Sparks, MD
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