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Class 2 Device Recall AxSYM TroponinI Reagent Kit |
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Date Initiated by Firm |
March 26, 2004 |
Date Posted |
July 20, 2004 |
Recall Status1 |
Terminated 3 on October 14, 2004 |
Recall Number |
Z-0782-04 |
Recall Event ID |
28649 |
510(K)Number |
K974103
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Product Classification |
Immunoassay Method, Troponin Subunit - Product Code MMI
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Product |
AxSYM Troponin-I Reagent Kit, list 3C29-20, 100 test kit; Abbott Laboratories, Abbott Park, IL 60064 |
Code Information |
lot numbers 10264M300, 10264M301, 10265M300, and 10265M301 |
Recalling Firm/ Manufacturer |
Abbott Laboratories HPD/ADD/GPRD 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 |
An increase in complaints of higher than normal patient results, some from the healthy population range to above the diagnostic cutoff for an Acute Myocardial Infarction.
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FDA Determined Cause 2 |
Other |
Action |
Recalled by telephone calls on 3/26/04 and a follow-up letter dated 3/25/04. The accounts were informed of the elevated patient results for the Troponin-I Reagent lots, and were requested to discontinue use and destroy any of the four affected lots found in inventory. |
Quantity in Commerce |
7,394 kits |
Distribution |
Nationwide and internationally to Abbott affiliates in Argentina, Canada, Germany, Singapore, Hong Kong,
Taiwan, Australia, New Zealand, Thailand, China and Korea.
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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 = MMI and Original Applicant = ABBOTT LABORATORIES
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