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/ Manufacturer |
Abbott Laboratories MPG 100 Abbott Park Rd Abbott Park IL 60064-3502
|
For Additional Information Contact |
Abbott 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 |
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
|