Class 2 Device Recall IMx Tacrolimus II Assay

• Date Initiated by Firm: November 13, 2003
• Date Posted: December 17, 2003
• Recall Status: Terminated on October 29, 2004
• Recall Number: Z-0230-04
• Recall Event ID: 27717
• PMA Number: P970007
• Product Classification: Enzyme Immunoassay, Tracrolimus - Product Code MLM
• Product: IMx Tacrolimus II Assay, list 3C10-20; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064
• Code Information: All lot numbers
• Recalling Firm/ Manufacturer: Abbott Laboratories HPD/ADD/GPRD; 100/200 Abbott Park Road; Abbott Park IL 60064
• For Additional Information Contact: Abbott Customer Support; 877-422-2688
• Manufacturer Reason for Recall: Inadequate instructions for use resulting in calibration errors and the protein interference data in the package insert is not representative of assay performances.
• FDA Determined Cause: Other
• Action: Device correction recall initiated by letters dated 11/12/03. Letters were sent to all current IMx Tacrolimus II customers worldwide, advising them that calibration errors and controls out of range be the result of variance with the sample pretreatment steps listed in the package insert, and that the protein interference data in the insert is not representative of assay performance (12% when it should state less than 22% error) . A Customer Training Guide was included in the letter, outlining steps to aid the assay user in performing the pretreatment step and listing the most common deviations that can impact results.
• Quantity in Commerce: not lot specific
• Distribution: Nationwide and internationally to Guatemala, Venezuela, Columbia, Peru, Chile, Australia, Panama, Argentina, Puerto Rico, Dominican Republic, Canada, Germany, New Zealand, England, Japan, Singapore, Thailand, Korea and Costa Rica.
• 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.

• PMA Database: PMAs with Product Code = MLM