FDA recall Z-2291-2020

Product

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

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.

Distribution

US: TX, MA, TN, MO, IN

Key facts

Status

Terminated

Initiation date

2019-10-10

Report date

2020-06-17

Termination date

2020-12-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pacheco, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2291-2020