Home / Recalls / Dako North America Inc. / Z-0220-2016

Z-0220-2016 Class II Terminated

Recalled by Dako North America Inc. — Carpinteria, CA

Recall Details

Product Type
Devices
Report Date
November 11, 2015
Initiation Date
September 4, 2015
Termination Date
April 25, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
300 units

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and to the states of : 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, and DC., and to the countries of : Canada, Brazil and Costa Rica.

Code Information

Item No.: K800021-2, K800221-2, K802321-2 (Link) K801021-2, K801221-2, K802421-2 (AS/AS+) GV80011-2, GV82311-2 (Dako Omnis) Catalog/Model No.: K8000 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

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  • Z-1261-2015 Class II — Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostain (February 12, 2015)
  • Z-2708-2014 Class II — Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS480 (August 29, 2014)
  • Z-1093-2014 Class II — Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109, lot 20000910 (January 21, 2014)
  • Z-0287-2013 Class II — PT Link Waterbath, Model#PT100. Lab Vision PT Module Plus provides an automat (May 1, 2008)