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U.S. Department of Health and Human Services

Class 2 Device Recall IMx Tacrolimus II Assay

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  Class 2 Device Recall IMx Tacrolimus II Assay see related information
Date Initiated by Firm November 13, 2003
Date Posted December 17, 2003
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = Abbott Laboratories
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