Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

4plus Streptavidin HRP Label Recalled by Biocare Medical, LLC Due to Firm has identified product has no staining. If...

Date: October 10, 2019
Company: Biocare Medical, LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Biocare Medical, LLC directly.

Affected Products

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

Quantity: 8

Why Was This 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.

Where Was This Sold?

This product was distributed to 5 states: IN, MA, MO, TN, TX

Affected (5 states)Not affected

About Biocare Medical, LLC

Biocare Medical, LLC has 9 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report