Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

ISH Protease 3, Catalog Number 05273331001, model 780-4149 Immunohistochemistry (IHC) for in vitro diagnostic use.

FDA Recall Z-3005-2018 · Posted 2018-09-14

Recalling FirmVentana Medical Systems Inc
Recall StatusTerminated
Product CodeIBG
Date Initiated2018-08-02
Date Terminated2021-11-22
Product Quantity2231 units

Reason for Recall

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

Firm Action

The firm disseminated their field safety notices by letter on 08/02/2018. The firm requested the destruction of the product.

Root Cause

Under Investigation by firm

Distribution Pattern

worldwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑