IMx Tacrolimus II Assay, list 3C10-20; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064
- Company
- Abbott Laboratories Hpd/Add/Gprd
- Recall Initiated
- November 13, 2003
- Posted
- December 17, 2003
- Terminated
- October 29, 2004
- Recall Number
- Z-0230-04
- Quantity
- not lot specific
- Firm Location
- Abbott Park, IL
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.
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.
Lot / Code Info
All lot numbers
Root Cause
Other
Action Taken
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.