Reported Nov 11, 2015 · Terminated

EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+,…

Dako North America Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Dako North America Inc. · 6392 Via Real · Carpinteria, CA · 93013-2921

Is this the product you have?

EnVision FLEX/HRP visualization
reagent found in the following kitsEnVision 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

Lot codes and dates: 7 of 7 products
Products covered by this recall
Model / number Product as published
K8000 Item No.: K800021-2, K800221-2, K802321-2 (Link) K801021-2, K801221-2, K802421-2 (AS/AS+) GV80011-2, GV82311-2 (Dako Omnis) Catalog/ K8002 K8023 GV800 SM802 EnVision FLEX / HRP
— Lot 20019374 used in: Envision FLEX, High pH (link)
— Lot No.: 20019097, 20020777, 20021381 Envision FLEX+, Mouse, High pH (link)
— Lot No.: 20019103, 20019113, 20020772 EnVision FLEX Mini Kit, High pH (Link)
— Lot No.: 20021362 DM 842 EnVision FLEX / HRP (Dako Omnis)
— Lot 20019013 used in: EnVision FLEX, High pH (Dako Omnis)
— Lot No.: 20019102
Amount recalled: 300 units

Where it was sold

Nationwide
PR
TX
SD
CA
FL
MA
MD
WV
NC
OH
DE
MI
NJ
CO
HI
AR
NY
LA
GA
NV
RI
IL
OK
CT
MO
VA
DC

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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By hazard

Medical device recalls

Other recalls from Dako North America Inc.

7 in total.

Where it was distributed

All recall categories · Browse the whole archive

Model / number	Product as published
`K8000`	Item No.: K800021-2, K800221-2, K802321-2 (Link) K801021-2, K801221-2, K802421-2 (AS/AS+) GV80011-2, GV82311-2 (Dako Omnis) Catalog/ K8002 K8023 GV800 SM802 EnVision FLEX / HRP
—	Lot 20019374 used in: Envision FLEX, High pH (link)
—	Lot No.: 20019097, 20020777, 20021381 Envision FLEX+, Mouse, High pH (link)
—	Lot No.: 20019103, 20019113, 20020772 EnVision FLEX Mini Kit, High pH (Link)
—	Lot No.: 20021362 DM 842 EnVision FLEX / HRP (Dako Omnis)
—	Lot 20019013 used in: EnVision FLEX, High pH (Dako Omnis)
—	Lot No.: 20019102