IMx Tacrolimus II Assay, list 3C10-20; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064

FDA device recall Z-0230-04 · posted 2003-12-17 · Terminated

Recall details

Recalling firm

Abbott Laboratories HPD/ADD/GPRD

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.

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.

Root cause

Other

Status

Terminated

Product code

MLM

Quantity affected

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, T

Date initiated

2003-11-13

Date posted

2003-12-17

Date terminated

2004-10-29

Location

Abbott Park, IL