Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall ARCHITECT STAT TroponinI Reagent Kit

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall ARCHITECT STAT TroponinI Reagent Kitsee related information
Date Initiated by FirmDecember 21, 2005
Date PostedFebruary 14, 2006
Recall Status1 Terminated 3 on July 31, 2006
Recall NumberZ-0513-06
Recall Event ID 34297
510(K)NumberK041192 
Product Classification Immunoassay Method, Troponin Subunit - Product Code MMI
ProductARCHITECT 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
FEI Number 1415939
Recalling Firm/
Manufacturer		 Abbott Laboratories MPG
100 Abbott Park Rd
Abbott Park IL 60064-3502
For Additional Information ContactAbbott Customer Support
877-422-2688
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		Other
ActionAbbott 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 Commerce181 kits
DistributionNationwide and internationally to Canada, Australia, Germany and Taiwan
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
-
-