FDAClass IIJune 17, 2020

4plus Streptavidin HRP Label recall

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

Why was 4plus Streptavidin HRP Label 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number: 041619-4, Expiration Date: 2020/10

Product
4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H
Recalling firm
Biocare Medical, LLC
Quantity
8
Distribution
US: TX, MA, TN, MO, IN
Recall date
June 17, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls