Biocare Medical, LLC recalls 4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP60…

Recall date

October 10, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2291-2020

FDA classification

Class II

Brand / firm

Biocare Medical, LLC

Sold / distributed

US: TX, MA, TN, MO, IN

Why it was recalled

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.

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

What was recalled

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