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Terminated

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

FDA Recall Z-3006-2018 · Posted 2018-09-14

Recalling FirmVentana Medical Systems Inc
Recall StatusTerminated
Product CodeMXZ
Date Initiated2018-08-02
Date Terminated2021-11-22
Product Quantity1655 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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K103818CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODYVentana Medical Sytems, Inc. · 2011-11-16

Official Source

View FDA Recall →

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

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