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U.S. Department of Health and Human Services

Class 2 Device Recall IMx AFP Calibrators

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  Class 2 Device Recall IMx AFP Calibrators see related information
Date Initiated by Firm March 04, 2003
Date Posted April 16, 2003
Recall Status1 Terminated 3 on September 04, 2003
Recall Number Z-0726-03
Recall Event ID 25689
PMA Number P820060 
Product Classification Kit, Test,Alpha-Fetoprotein For Testicular Cancer - Product Code LOJ
Product Abbott IMx AFP Calibrators, list 2271-01; a box of 6 bottles (4 mL each) with AFP (human), nonreactive for anti-HIV-1/HIV-2 and HCV and nonreactive for HBsAg, inbuffered calf serum at the following concentrations: A - 0, B - 15, C - 50, D - 100, E - 200 and F - 350; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott park, IL 60064
Code Information lot number 89651M300, exp. 04/20/03
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 IMx AFP Calibrators may cause depressed values for the IMx AFP Low Control, and cause patient results to be 20% lower than actual values
FDA Determined
Cause 2		 Other
Action Recalled by letter dated 3/4/03. The laboratory accounts were informed of the lot of calibrators causing depressed values for the IMx AFP Low Control, requested to destroy any of the suspect lot of calibrators, and recalibrate the AFP assay using a different lot of calibrators.
Quantity in Commerce 107 kits
Distribution Nationwide
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.
PMA Database PMAs with Product Code = LOJ and Original Applicant = Abbott Laboratories
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