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U.S. Department of Health and Human Services

Class 2 Device Recall EnVision FLEX, EnVision FLEX, EnVision FLEX Mini Kit

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  Class 2 Device Recall EnVision FLEX, EnVision FLEX, EnVision FLEX Mini Kit see related information
Date Initiated by Firm September 04, 2015
Date Posted November 05, 2015
Recall Status1 Terminated 3 on April 25, 2016
Recall Number Z-0220-2016
Recall Event ID 72097
Product Classification Reagent, general purpose - Product Code LDT
Product 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.
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   
Recalling Firm/
Manufacturer		 Dako North America Inc.
6392 Via Real
Carpinteria CA 93013-2921
For Additional Information Contact
805-566-6655
Manufacturer 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.
FDA Determined
Cause 2		 Other
Action Dako sent an customer notification letter on September 4, 2015, to all affected customers via mail. The letter identified the product the problem and the action needed to be taken by the customer. The customers/distributors are instructed in the Recall Notification Letters to 1) remove any unused kits bearing the affected lot numbers listed in their letter from diagnostic use 2) destroy any unused kits bearing the affect lot numbers listed in their letter, and 3) determine any possible impact of this change in performance on patient results from the affected lots. The letter states actions should be taken within 10 days and that customers/distributors should confirm they have received the information by returning the attached, fully completed Device Recall Form and return it to Dako QA Vigilance by email at dako.dkvigilance@dako.com. The firm lists on their letter for customers to contact their Dako representative in there are any questions. For further questions, call (805) 566-6655.
Quantity in Commerce 300 units
Distribution 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.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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