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

iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model 760-093. For laboratory use.

FDA Recall Z-3001-2018 · Posted 2018-09-14

Recalling FirmVentana Medical Systems Inc
Recall StatusTerminated
Product CodeNJT
Date Initiated2018-08-02
Date Terminated2021-11-22
Product Quantity10 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.

↑