Medical device recalls Moderate risk

Becton Dickinson & Co. recalls BD COR System Software. Model Number: 444829.

Recall date
June 23, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2162-2025
FDA classification
Class II
Brand / firm
Becton Dickinson & Co.
Sold / distributed
Worldwide - US Nationwide distribution in the states of Florida, Texas and Michigan. The countries of Sweden and Belgium.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BD COR System Software. Model Number: 444829.

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