Recall Z-0230-04 ยท MLM Enzyme Immunoassay, Tracrolimus
Abbott Laboratories HPD/ADD/GPRD
IMx Tacrolimus II Assay, list 3C10-20; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064
| Date | Dec 17, 2003 (initiated Nov 13, 2003) |
| Status | Terminated |
| Reason | Inadequate instructions for use resulting in calibration errors and the protein interference data in the package insert is not representative of assay performances. |
| Root 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 deviatio |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.