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U.S. Department of Health and Human Services

Class 1 Device Recall ARCHITECT STAT TroponinI Reagent

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  Class 1 Device Recall ARCHITECT STAT TroponinI Reagent see related information
Date Initiated by Firm March 08, 2007
Date Posted June 14, 2007
Recall Status1 Terminated 3 on July 16, 2008
Recall Number Z-0855-2007
Recall Event ID 37570
510(K)Number K041192  
Product Classification Troponin-I Reagent - Product Code MMI
Product ARCHITECT STAT Troponin-I Reagent; list numbers 2K41-20 (400 test kit), 2K41-25 (100 test kit) and 2K41-30 (2000 test kit); each kit contains bottles of microparticles, conjugate and assay diluent; Abbott Laboratories, Abbott Park, IL 60064
Code Information Lot numbers 11455C006, 11605UN06, 12072UN06, 14818UN06, 13037UN06, 12990UN06, 12982UN06, 11456C006, 11609UN06, 14817UN06, 14339UN06, 13590UN06, 12986UN06, 14350UN06, 13122UN06, 12978UN06, 11370C006
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
False Negative Results : The analytical sensitivity claim of less than or equal to 0.01 ng/mL (ug/L) might not be met for all lots of Architect STAT Troponin-I reagents, thus false negative results may occur with negative results less than 0.1 ng/mL
FDA Determined
Cause 2
Action Abbott sent a Product Correction letter on 3/8/07 to all Troponin-I customers who received reagent lots in the last 12 months. The letters informed the accounts that the analytical sensitivity claim of
Quantity in Commerce 9,438 kits
Distribution Worldwide: USA including Puerto Rico, and internationally to Canada, Brazil, Germany, Japan, Taiwan, Hong Kong, Thailand, South Korea, Australia, New Zealand, Mexico, Colombia, Chile, Argentina and Trindad & Tobago.
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