FDAOctober 10, 2019device

4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H

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

The hazard

Firm has identified product has no staining. If used, may result in invalid test results when used with controls in the clinical setting. Positive control would observe no staining. The clinical impact may result in the consumption of patient tissue sample and a delay in diagnosis.

What to do

FDA enforcement status: Terminated

Brands named

biocare medicalbiocare

Recall history

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

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