FDAJuly 9, 2024device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

becton dickinsonbectonbecton dickinson

UPCs

00382904449001

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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