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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott AxSYM CA 153 Master Calibrator Pack

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 Class 2 Device Recall Abbott AxSYM CA 153 Master Calibrator Packsee related information
Date Initiated by FirmMarch 04, 2003
Date PostedMarch 26, 2003
Recall Status1 Terminated 3 on September 15, 2004
Recall NumberZ-0679-03
Recall Event ID 25690
510(K)NumberK963926 
Product Classification System, Test, Immunological, Antigen, Tumor - Product Code MOI
ProductAbbott AxSYM CA 15-3 Master Calibrator Pack, list 3B42-30; the pack contains two 4-mL bottles, with Master Calibrator 1 having 0 U/mL and Master Calibrator 2 having 60 U/mL; Abbott Laboratories, Abbott Park, IL 60064
Code Information list 3B42-50, lot 86504M300 
FEI Number 1415939
Recalling Firm/
Manufacturer		 Abbott Laboratories HPD/ADD
100/200 Abbott Park Road
Abbott Park IL 60064
For Additional Information ContactAbbott Customer Support
877-422-2688
Manufacturer Reason
for Recall		The CA 15-3 Calibrators may cause depressed values for the CA 15-3 High Control and for patient specimens.
FDA Determined
Cause 2		Other
ActionRecalled by letter dated 3/4/03. The accounts were informed of the depressed values for the CA 15-3 High Control and for patient specimens, and were requested to discontinue use and destroy any of the three affected lots found in inventory.
Quantity in Commerce958 packs
DistributionNationwide and Ecuador, England, Hong Kong, Chile, Japan, Canada, Singapore, Australia, Pakistan, Argentina, Thailand, Aruba, Korea and Jamaica.
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = MOI
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