Medical device recalls Moderate risk

Becton Dickinson & Co. recalls BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900;

Recall date
July 9, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2585-2024
FDA classification
Class II
Brand / firm
Becton Dickinson & Co.
Sold / distributed
US distribution to states of: CO, CT, IA, IL, KY, MD, MI, MN, NC, NJ, NY, OH, OK, SC, TN, TX and WA.

Why it was recalled

There is a potential risk that the image colony count does not adequately reflect the actual plate colony count and may lead to inaccurate counts that would impact patient diagnosis and subsequent care.

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 Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900;

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