Biocare Medical, LLC: Medical Device Recall in 2020 - (Recall #: Z-2291-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 10, 2019

Date Posted: June 17, 2020

Recall Number: Z-2291-2020

Event ID: 85359

Reason for Recall:

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.

Status: Terminated

Product Quantity: 8

Code Information:

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

Distribution Pattern:

US: TX, MA, TN, MO, IN

Voluntary or Mandated:

Voluntary: Firm initiated