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

iView DAB IHC Detection Kit, Ventana part Number 760-091, Roche GMMI 05266157001 in vitro diagnostic — recall Z-0731-2018

U.S. FDA — Device Enforcement · United States · 2017-12-19 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0731-2018
Date of alert
2017-12-19
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)
04015630971749
Reported risk: Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINtec PLUS Cytology Kit) and with Hematoxylin II.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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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.