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

Recall Z-3015-2018 — NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Catalog Number 05266084001 Model 760-041 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-3015-2018
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): 4015630970254

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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Recall Z-3015-2018 — NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Catalog Number 05266084001 Model 760-041 Immunohistochemistry (IHC) for in vitro diagnostic use.

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