Z-0230-04

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

Name: Z-0230-04 IMx Tacrolimus II Assay, list 3C10-20; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL...
Creator: Abbott Laboratories HPD/ADD/GPRD
Published: 2003-11-13
License: https://open.fda.gov/license/

Abbott Medical / initiated 2003-11-13 / Terminated / root cause: labeling and UDI

FDA source

Abbott Laboratories HPD/ADD/GPRD began a recall of IMx Tacrolimus II Assay, list 3C10-20; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064 on 2003-11-13. The reason FDA records is "Inadequate instructions for use resulting in calibration errors and the protein interference data in the package insert is not representative of assay performances". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0230-04
Status: Terminated
Initiated: 2003-11-13
Posted: 2003-12-17
Terminated: 2004-10-29
Recalling firm: Abbott Medical
Product: IMx Tacrolimus II Assay, list 3C10-20; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064
Product code: MLM Enzyme Immunoassay, Tracrolimus
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.
Root cause tag: labeling and UDI
FDA 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 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.
Product codes and lots: All lot numbers

Product code MLM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)