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

FDA device recall Z-0063-04 · posted 2003-10-24 · Terminated

Recall details

Recalling firm

Abbott Laboratories HPD/ADD/GPRD

Reason for recall

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

Action taken

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

Status

Terminated

Product code

MLM

Quantity affected

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.

Date initiated

2003-09-19

Date posted

2003-10-24

Date terminated

2004-10-29

Location

Abbott Park, IL