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Class 2 Device Recall IMx CA 153 Reagent 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-0681-03 |
Recall Event ID |
25690 |
510(K)Number |
K964407
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Product Classification |
System, Test, Immunological, Antigen, Tumor - Product Code MOI
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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
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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 |
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
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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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