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U.S. Department of Health and Human Services

Class 2 Device Recall CA 153 Calibrator Pack

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 Class 2 Device Recall CA 153 Calibrator Packsee related information
Date Initiated by FirmMarch 04, 2003
Date PostedMarch 26, 2003
Recall Status1 Terminated 3 on September 15, 2004
Recall NumberZ-0680-03
Recall Event ID 25690
510(K)NumberK963926 K964407 
Product Classification System, Test, Immunological, Antigen, Tumor - Product Code MOI
ProductCA 15-3 Calibrators, list 9C08-01; the pack contains six 4-mL bottles of 115D8:DF3 reactive determinants prediluted in TRIS buffer with protein stabilizers to yield the following assay values: A - 0 u/mL, B - 15 U/mL, C - 60 U/mL, D - 120 U/mL, E - 180 U/mL and F - 250 U/mL; Abbott Laboratories, Abbott Park, IL 60064
Code Information list 9C08-01, lot 88127M100 
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 Commerce792 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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