Date Initiated by Firm |
September 06, 2005 |
Date Posted |
October 06, 2005 |
Recall Status1 |
Terminated 3 on January 26, 2012 |
Recall Number |
Z-0009-06 |
Recall Event ID |
33453 |
510(K)Number |
K965240 K011213 K023049
|
Product Classification |
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
|
Product |
Synchron LX Systems Version 4.5 Operating Software
|
Code Information |
Synchron LX 20 and PRO Version 4.5 Operating Software Part Number A21127 (Upgrade Kit) Software Versions V4.5N4.6 CDB (Chemistry Database). Synchron LXi Version 4.5 Operating Software A21128 (Upgrade Kit) Software Versions V4.5N4.6 CDB(Chemistry Database). |
Recalling Firm/ Manufacturer |
Beckman Coulter Inc 200 S Kraemer Blvd Brea CA 92822-6208
|
For Additional Information Contact |
Nancy E. Johnson 714-961-4489
|
Manufacturer Reason for Recall |
Synchron LX Systems Operating Software Version 4.5/v4.6 CBD (Chemistry Database) introduced an adjustment to the urine Uric Acid database calculation scheme which for some patients, depending on the volume of 24 hour urine sample, results may be reduced from above the upper limit of the laboratory's reference interval to below the limit.
|
FDA Determined Cause 2 |
Software design |
Action |
Customers were notified by letter dated September 6, 2005 with work around instruction provided in the letter. |
Quantity in Commerce |
868 |
Distribution |
Nationwide and 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 = JJE and Original Applicant = BECKMAN COULTER, INC. 510(K)s with Product Code = JJE and Original Applicant = BECKMAN INSTRUMENTS, INC.
|