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Class 2 Device Recall CA 153 Calibrator Pack |
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Date Initiated by Firm |
March 04, 2003 |
Date Posted |
March 26, 2003 |
Recall Status1 |
Terminated 3 on September 15, 2004 |
Recall Number |
Z-0680-03 |
Recall Event ID |
25690 |
510(K)Number |
K963926 K964407
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Product Classification |
System, Test, Immunological, Antigen, Tumor - Product Code MOI
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Product |
CA 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
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For Additional Information Contact |
Abbott Customer Support 877-422-2688
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Manufacturer Reason for Recall |
The CA 15-3 Calibrators may cause depressed values for the CA 15-3 High Control and for patient specimens.
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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 |
792 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
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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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510(K) Database |
510(K)s with Product Code = MOI and Original Applicant = ABBOTT LABORATORIES
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