Z-0063-04

IMx Tacrolimus II Calibrators, list 3C10-10; the pack contains six 4.5-mL bottles, with Calibrator A having 0...

Name: Z-0063-04 IMx Tacrolimus II Calibrators, list 3C10-10; the pack contains six 4.5-mL bottles, with Calibrator A having 0...
Creator: Abbott Laboratories HPD/ADD/GPRD
Published: 2003-09-19
License: https://open.fda.gov/license/

Abbott Medical / initiated 2003-09-19 / Terminated / root cause: manufacturing process

FDA source

Abbott Laboratories HPD/ADD/GPRD began a recall of IMx Tacrolimus II Calibrators, list 3C10-10; the pack contains six 4.5-mL bottles, with Calibrator A having 0 ng/mL, Calibrator B having 3 ng/mL, Calibrator C... on 2003-09-19. The reason FDA records is "Invalid test results are being generated due to calibration errors when using calibrator lots 94165M100 and 94164M100". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0063-04
Status: Terminated
Initiated: 2003-09-19
Posted: 2003-10-24
Terminated: 2004-10-29
Recalling firm: Abbott Medical
Product: IMx Tacrolimus II Calibrators, list 3C10-10; the pack contains six 4.5-mL bottles, with Calibrator A having 0 ng/mL, Calibrator B having 3 ng/mL, Calibrator C having 6 ng/mL, Calibrator D having 12 ng/mL, Calibrator E having 20 ng/mL and Calibrator F having 30 U/mL; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064
Product code: MLM--
Reason for recall: Invalid test results are being generated due to calibration errors when using calibrator lots 94165M100 and 94164M100.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Recalled by letters dated 9/19/03 and 10/7/03. The accounts were informed of the inability to calibrate the IMx Tacrolimus II assay when using calibrator lots 94165M100 and 94164M100, and initially requested those accounts experiencing an increase in calibration-related errors to report the issue to Abbott for a replacement calibrator kit. The 10/7/03 letter requested the accounts to discontinue use and destroy any of the two affected calibrator lots found in inventory.
Quantity in commerce: 2677 kits
Distribution: Nationwide and internationally to Guatemala, Venezuela, Peru, Argentina, Dominican Republic, Canada, Japan, Singapore, Thailand, Korea, Australia, Costa Rica, Panama and Great Britain.
Product codes and lots: list 3C10-10, lots 94165M100 and 94164M100

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)