Date Initiated by Firm |
October 10, 2003 |
Date Posted |
July 20, 2004 |
Recall Status1 |
Terminated 3 on July 16, 2004 |
Recall Number |
Z-1098-04 |
Recall Event ID |
29054 |
510(K)Number |
k965240 k014034 k011213 k023049
|
Product Classification |
unknown device name - Product Code EXEMP
|
Product |
Synchron LX Clinical Systems, Operating Software, All versions. |
Code Information |
All Versions. |
Recalling Firm/ Manufacturer |
Beckman Coulter Inc 200 S Kraemer Blvd Brea CA 92822-6208
|
Manufacturer Reason for Recall |
Numeric results are erroneously accepted by the in-house information system without qualifying symbols "<" or ">". In addition, the in-house system may interpret the results incorrectly.
|
FDA Determined Cause 2 |
Other |
Quantity in Commerce |
816 |
|
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 = EXEMP and Original Applicant = BECKMAN COULTER, INC. 510(K)s with Product Code = EXEMP and Original Applicant = BECKMAN INSTRUMENTS, INC.
|