Medical device recalls Moderate risk

Becton Dickinson & Co. recalls BD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing Catalog Number : 447213

Recall date
July 26, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2439-2019
FDA classification
Class II
Brand / firm
Becton Dickinson & Co.
Sold / distributed
Illinois, Iowa, Missouri, New York, Ohio, Tennessee World Wide (5): Singapore, Taiwan, France, Netherlands

Why it was recalled

An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate

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 Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing Catalog Number : 447213

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