FDA-Device2025-07-30Class II
BD COR System Software. Model Number: 444829.
Becton Dickinson & Co.
Hazard
Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.
Sold states
Worldwide - US Nationwide distribution in the states of Florida, Texas and Michigan. The countries of Sweden and Belgium.
Affected count
7 systems
Manufactured in
7 Loveton Cir, N/A, Sparks, MD, United States
Products
BD COR System Software. Model Number: 444829.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2162-2025Don't want to check this manually?
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