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Terminated

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

FDA Recall Z-0063-04 · Posted 2003-10-24

Recalling FirmAbbott Laboratories HPD/ADD/GPRD
Recall StatusTerminated
Product CodeMLM
Date Initiated2003-09-19
Date Terminated2004-10-29
Product Quantity2677 kits

Reason for Recall

Invalid test results are being generated due to calibration errors when using calibrator lots 94165M100 and 94164M100.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide and internationally to Guatemala, Venezuela, Peru, Argentina, Dominican Republic, Canada, Japan, Singapore, Thailand, Korea, Australia, Costa Rica, Panama and Great Britain.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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