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U.S. Department of Health and Human Services

Class 2 Device Recall AxSYM TroponinI Reagent Kit

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 Class 2 Device Recall AxSYM TroponinI Reagent Kitsee related information
Date Initiated by FirmMarch 26, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on October 14, 2004
Recall NumberZ-0782-04
Recall Event ID 28649
510(K)NumberK974103 
Product Classification Immunoassay Method, Troponin Subunit - Product Code MMI
ProductAxSYM 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
FEI Number 1415939
Recalling Firm/
Manufacturer		 Abbott Laboratories HPD/ADD/GPRD
100/200 Abbott Park Road
Abbott Park IL 60064
For Additional Information ContactAbbott Customer Support
877-422-2688
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.
FDA Determined
Cause 2		Other
ActionRecalled 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 Commerce7,394 kits
DistributionNationwide and internationally to Abbott affiliates in Argentina, Canada, Germany, Singapore, Hong Kong, Taiwan, Australia, New Zealand, Thailand, China and Korea.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MMI
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