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

Recall Z-0220-2016 — EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.

U.S. FDA — Device Enforcement · United States · 2015-09-04 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0220-2016
Date of alert
2015-09-04
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Dako North America Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
20019374
Reported risk: There is a defect in one lot of a buffer, non-specific background staining that has, in some instances, interfered with interpretation of the staining results.
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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