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U.S. Department of Health and Human Services

Class 2 Device Recall IMx CA 153 Reagent Pack

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  Class 2 Device Recall IMx CA 153 Reagent Pack see related information
Date Initiated by Firm March 04, 2003
Date Posted March 26, 2003
Recall Status1 Terminated 3 on September 15, 2004
Recall Number Z-0681-03
Recall Event ID 25690
510(K)Number K964407  
Product Classification System, Test, Immunological, Antigen, Tumor - Product Code MOI
Product IMx CA 15-3 Reagent Pack, list 6A75-22; this reagent pack contains one 4-mL bottle of Mode 1 Calibrator along with other reagents; Abbott Laboratories, Abbott Park, IL
Code Information list 6A75-22, lot 90843M200
Recalling Firm/
Manufacturer		 Abbott Laboratories HPD/ADD
100/200 Abbott Park Road
Abbott Park IL 60064
For Additional Information Contact Abbott 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
Action Recalled 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 Commerce 409 packs
Distribution Nationwide and Ecuador, England, Hong Kong, Chile, Japan, Canada, Singapore, Australia, Pakistan, Argentina, Thailand, Aruba, Korea and Jamaica.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = MOI and Original Applicant = ABBOTT LABORATORIES
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