Date Initiated by Firm |
July 29, 2004 |
Date Posted |
August 17, 2004 |
Recall Status1 |
Terminated 3 on February 03, 2005 |
Recall Number |
Z-1378-04 |
Recall Event ID |
29690 |
510(K)Number |
K984014
|
Product Classification |
Calibrator, Multi-Analyte Mixture - Product Code JIX
|
Product |
SYNCHRON Clinical Systems Enzyme Validator Kit |
Code Information |
M310400 |
Recalling Firm/ Manufacturer |
Beckman Coulter Inc 200 S Kraemer Blvd Brea CA 92822-6208
|
For Additional Information Contact |
Kathleen M. Jaker 714-961-3666
|
Manufacturer Reason for Recall |
incorrect Calibration Acceptance Limits.
|
FDA Determined Cause 2 |
Other |
Action |
Recall letter sent 07/29/2004, informing customers to discard all calibration diskettes and load a new calibration diskette. |
Quantity in Commerce |
771 |
Distribution |
Nationwide & Canada |
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 = JIX and Original Applicant = BECKMAN COULTER, INC.
|