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

VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-1015 Immunohistochemistry (IHC) for in vitro diagnostic use. — recall Z-3010-2018

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-3010-2018
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)
4015630970018
Reported risk: Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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