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

Recall Z-0735-2018 — CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche GMMI 06889549001 in vitro diagnostic

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-0735-2018
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)
04015630976287
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.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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