Class 2 Device Recall Architect Tacrolimus Reagent Kit

• Date Initiated by Firm: September 07, 2010
• Date Posted: October 15, 2010
• Recall Status: Terminated on May 13, 2011
• Recall Number: Z-0068-2011
• Recall Event ID: 56719
• 510(K)Number: K070820
• Product Classification: enzyme immunoassay, tracrolimus - Product Code MLM
• Product: Architect Tacrolimus Reagent Kit; an in-vitro diagnostic chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of tacrolimus in human whole blood; Abbott Laboratories, Abbott Diagnostics Division, Abbott Park, IL 60064 USA; list 1L77-25; ; The Architect Tacrolimus assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of tacrolimus in human whole blood as an aid in the management of liver and kidney allograft patients receiving tacrolimus therapy.
• Code Information: list 1L77-25, lot number 86599M500, expiration date September 01, 2011
• Recalling Firm/ Manufacturer: Abbott Laboratories; 100 Abbott Park Rd; Abbott Park IL 60064-3502
• For Additional Information Contact: Customer Service; 877-422-2688
• Manufacturer Reason for Recall: There are reagent barcode read errors when using reagent lot 86599M500 due to the print quality of the barcode.
• FDA Determined Cause: Other
• Action: Abbott Laboratories sent a "Product Recall Immediate Action Required" letter dated September 7, 2010, to all customers. The letter described product, problem and action to be taken by customers. The customers were instructed to determine if they are currently using and/or have inventory of lot 86599M500; discontinue use of and destroy any remaining inventory; inform and provide copies of letter to other laboratories if appropriate; retain the letter for laboratory records and complete and return the Customer Reply Immediate Action Required form via fax at 1-800-777-0051 or email QAGCO@abbott.com. IMPORTANT NOTE: If you do not currently have replacement material than you may continue to use this reagent lot until your laboratory receives replacement material. Upon receipt of the replacement material, discontinue use of and discard lot 86599M500 and switch to the replacement material. Contact Abbott Customer service for replacement material (1-877-4ABBOTT, Option 1). If you or any of the health care providers you serve have any questions regarding this information, U.S. customers should call Customers Service at 1-877-4ABBOTT. Customers outside of the U.S., please contact your local Customer Service representative.
• Quantity in Commerce: 1,995 kits
• Distribution: Worldwide distribution: USA and countries including Puerto Rico, Argentina, Australia, Austria, Belarus, Belgium, Bosnia, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Egypt, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Lithuania, Montenegro, Netherlands, New Zealand, Norway, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom and Vietnam.
• 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.

• 510(K) Database: 510(K)s with Product Code = MLM and Original Applicant = FUJIREBIO DIAGNOSTICS, INC.