Abbott Laboratories HPD/ADD/GPRD 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Abbott Laboratories HPD/ADD/GPRD
Lot Codes / Batch Numbers
list 3C10-10, lots 94165M100 and 94164M100
Products Sold
list 3C10-10, lots 94165M100 and 94164M100
Abbott Laboratories HPD/ADD/GPRD is recalling IMx Tacrolimus II Calibrators, list 3C10-10; the pack contains six 4.5-mL bottles, with Calibrator A due to Invalid test results are being generated due to calibration errors when using calibrator lots 94165M100 and 94164M100.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Invalid test results are being generated due to calibration errors when using calibrator lots 94165M100 and 94164M100.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026