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U.S. Department of Health and Human Services

Class 2 Device Recall IMx Tacrolimus II Calibrators

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 Class 2 Device Recall IMx Tacrolimus II Calibratorssee related information
Date Initiated by FirmSeptember 19, 2003
Date PostedOctober 24, 2003
Recall Status1 Terminated 3 on October 29, 2004
Recall NumberZ-0063-04
Recall Event ID 27374
PMA NumberP970007 
Product Classification unknown device name - Product Code MLM--
ProductIMx 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
Code Information list 3C10-10, lots 94165M100 and 94164M100
Recalling Firm/
Manufacturer		 Abbott Laboratories HPD/ADD/GPRD
100/200 Abbott Park Road
Abbott Park IL 60064
For Additional Information ContactAbbott Customer Support
877-422-2688
Manufacturer Reason
for Recall		Invalid test results are being generated due to calibration errors when using calibrator lots 94165M100 and 94164M100.
FDA Determined
Cause 2		Other
ActionRecalled 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 Commerce2677 kits
DistributionNationwide and internationally to Guatemala, Venezuela, Peru, Argentina, Dominican Republic, Canada, Japan, Singapore, Thailand, Korea, Australia, Costa Rica, Panama and Great Britain.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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