Class 2 Device Recall EnVision Model Number K4006

• Date Initiated by Firm: October 14, 2005
• Date Posted: December 23, 2005
• Recall Status: Terminated on January 29, 2007
• Recall Number: Z-0315-06
• 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 K4006
• Code Information: K4006: Lots 045172 & 075112
• 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: Other
• Action: Notification letter dated October 14, 2005 was sent by certified mail to cosignees instructing dosposal of product.
• Quantity in Commerce: Lots 045172=199 & 075112=112
• 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.