medical Class II Updated 2020-06-17

Biocare Medical, LLC recalls 4plus Streptavidin HRP Label, Conjugated Streptavidin Horse

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Affected States: TX, MA, TN, MO, IN
Lot/Code Info: Lot Number: 041619-4, Expiration Date: 2020/10
View official government recall

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