FDA recall Z-2162-2025

Becton Dickinson & Co. · Class II · device

Product

BD COR System Software. Model Number: 444829.

Reason for recall

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

Distribution

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

Key facts

Status
Ongoing
Initiation date
2025-06-23
Report date
2025-07-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Sparks, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2162-2025