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U.S. Department of Health and Human Services

Class 2 Device Recall ARCHITECT Cyclosporine

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  Class 2 Device Recall ARCHITECT Cyclosporine see related information
Date Initiated by Firm October 07, 2011
Date Posted November 04, 2011
Recall Status1 Terminated 3 on November 07, 2012
Recall Number Z-0162-2012
Recall Event ID 60094
510(K)Number K080751  
Product Classification Cyclosporine - Product Code MKW
Product ARCHITECT Cyclosporine; an in-vitro diagnostic chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cyclosporine in human whole blood Distributed by Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA; list 1L75-25.

The ARCHITECT Cyclosporine assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cyclosporine in human whole blood on the ARCHITECT i System. The ARCHITECT Cyclosporine assay is used as an aid in the management of heart, liver and kidney transplant patients receiving cyclosporine therapy.
Code Information lots 95098M500 exp 12/21/2011; 96143M500 exp 01/20/2012; 96142M500 exp 01/20/2012; 01107M500 exp 02/24/2011; 02079M500 exp 02/24/2012; 03182M500 exp 05/19/2012; 05533M500 exp 05/19/2012; 04069M500 exp 06/02/2012; 06525M500 exp 06/02/2012; 05014M500 exp 06/23/2012; 07011M500 exp 06/23/2012 
Recalling Firm/
Abbott Laboratories
100 Abbott Park Rd
Abbott Park IL 60064-3502
For Additional Information Contact Customer Service
Manufacturer Reason
for Recall
The ARCHITECT Cyclosporine assay has the potential to generate falsely elevated or depressed results with patient samples due to precision exceeding the Package Insert claim of <15% total CV. Calibrators and Controls also have the potential to be impacted by the assay imprecision.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Abbott Laboratories sent a "PRODUCT RECALL" letter dated October 7, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to only run ARCHITECT Cyclosporine using Reaction Vessel (RV) lots manufactured with the same resin as follows: a) RV lots beginning with lot 06083P100 and higher can be used together or, b) RVs lots lower than 06083P100 can be used together. Any RV lot number that does not begin with a zero (e.g. 90032P100) should also be considered lower than 06083P100. Further instructions were included for the accounts to follow when running ARCHITECT Cyclosporine assays. A Customer Reply form was provided to customers to complete and return via fax at 1-800-777-0051. Customers can contact Abbott Customer Service at 1-877-4ABBOTT for questions regarding this notice. A second letter was sent to the accounts on 11/23/11 to simplify the instructions for identifying the Architect Reaction Vessel lots that can be used together for use with the Architect Cyclosporine assay.
Quantity in Commerce 8,913 kits
Distribution Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Argentina, Australia, Austria, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei, Canada, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela 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 = MKW and Original Applicant = FUJIREBIO DIAGNOSTICS, INC.