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U.S. Department of Health and Human Services

Class 2 Device Recall EnVision Model Number K4001

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  Class 2 Device Recall EnVision Model Number K4001 see related information
Date Initiated by Firm October 14, 2005
Date Posted December 23, 2005
Recall Status1 Terminated 3 on January 29, 2007
Recall Number Z-0311-06
Recall Event ID 33957
Product Classification Immunohistochemistry Reagents And Kits - Product Code NJT
Product EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4001
Code Information K4001: Lots 045036, 065022, 085032
Recalling Firm/
Manufacturer		 Dakocytomation California Inc
6392 Via Real
Carpinteria CA 93013-2921
For Additional Information Contact Scot D. Kinghorn
805-566-5478
Manufacturer Reason
for Recall		 This recall has been initiated due to a formulation error in the EnVision+ visualization reagent.
FDA Determined
Cause 2		 Other
Action Notification letter dated October 14, 2005 was sent by certified mail to cosignees instructing dosposal of product.
Quantity in Commerce Lots 045036=632, 065022=805 &, 085032=274
Distribution Nationwide to: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MN, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, and WV. Worldwide to: Argentina, Bermuda, Brazil, Canada, Costa Rica, Denmark, Japan, Mexico, New Zealand, and Uruguay.
Total Product Life Cycle TPLC Device Report
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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