FDA recall Z-3006-2018

Product

CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody, Catalog Number 05278392001, model 790-4296 Immunohistochemistry (IHC) for in vitro diagnostic use.

Reason for recall

Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.

Distribution

worldwide

Key facts

Status

Terminated

Initiation date

2018-08-02

Report date

2018-09-26

Termination date

2021-11-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Oro Valley, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3006-2018