Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-3003-2018 — ANTI-PAN Keratin Primary Antibody, 25 mL, Catalog Number 05266840001, model 760-2135 Immunohistochemistry (IHC) for in vitro diagnostic use.

U.S. FDA — Device Enforcement · United States · 2018-08-02 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-3003-2018
Date of alert: 2018-08-02
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Ventana Medical Systems Inc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 4015630971572

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-3003-2018 — ANTI-PAN Keratin Primary Antibody, 25 mL, Catalog Number 05266840001, model 760-2135 Immunohistochemistry (IHC) for in vitro diagnostic use.

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