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U.S. Department of Health and Human Services

Class 2 Device Recall ARCHITECT STAT TroponinI Reagent Kit

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  Class 2 Device Recall ARCHITECT STAT TroponinI Reagent Kit see related information
Date Initiated by Firm December 21, 2005
Date Posted February 14, 2006
Recall Status1 Terminated 3 on July 31, 2006
Recall Number Z-0513-06
Recall Event ID 34297
510(K)Number K041192  
Product Classification Immunoassay Method, Troponin Subunit - Product Code MMI
Product ARCHITECT STAT Troponin-I Reagent Kit, list 2K41-20; each 400 test kit contains 4 bottles each of microparticles, conjugate and assay diluent; Abbott Laboratories, Abbott Park, IL 60064
Code Information list 2K41-20, lot 95567G005, exp 6-30-2006
Recalling Firm/
Abbott Laboratories MPG
100 Abbott Park Rd
Abbott Park IL 60064-3502
For Additional Information Contact Abbott Customer Support
Manufacturer Reason
for Recall
There has been an increase in customer complaints observed for failure to calibrate or inability to generate patient result errors.
FDA Determined
Cause 2
Action Abbott sent recall letters dated 12/20/05 to the laboratory accounts via Federal Express Priority on 12/21/05. The accounts were informed of the increase in customer complaints for failure to calibrate or inability to generate patient result errors for the Troponin-I Reagent lot, and were requested to discontinue use and destroy any of the affected lot found in inventory for replacement.
Quantity in Commerce 181 kits
Distribution Nationwide and internationally to Canada, Australia, Germany and Taiwan
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.
510(K) Database 510(K)s with Product Code = MMI and Original Applicant = FISHER DIAGNOSTICS