Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

BD COR System Software. Model Number: 444829.

FDA Recall Z-2162-2025 · Posted 2025-07-23

Recalling FirmBecton Dickinson & Co.
Recall StatusOpen, Classified
Product CodeMAQ
Date Initiated2025-06-23
Product Quantity7 systems

Reason for Recall

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

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑