|
Class 2 Device Recall Sysmex UF1000i Automated Urine Particle Analyzer with Urinalysis WAM |
|
Date Initiated by Firm |
March 31, 2013 |
Date Posted |
February 10, 2014 |
Recall Status1 |
Terminated 3 on August 15, 2016 |
Recall Number |
Z-0949-2014 |
Recall Event ID |
65214 |
510(K)Number |
K080887
|
Product Classification |
Counter, urine particle - Product Code LKM
|
Product |
The UF-1000i is a fully automated urine particle analyzer intended for vitro diagnostic use in urinalysis. The instrument can perform screening for abnormal samples with a high degree of accuracy, so it increases automation and efficiency in laboratories.
|
Code Information |
Software versions 1.0, 1.01, 1.1.1, 1.1.2 |
Recalling Firm/ Manufacturer |
Sysmex America, Inc. 1 Nelson C White Pkwy Mundelein IL 60060-9528
|
For Additional Information Contact |
Sysmex Technical Assistance Center 888-879-7639
|
Manufacturer Reason for Recall |
The current Century Break patch did not contain the same setting for the Century Break year for both the Red Hat Linux and GUI files. Due to the mismatch in file settings, the software could not properly calculate a purge date for the database files based on the customer data retention setting in the application. This resulted in the database files meeting its maximum capacity and causing system p
|
FDA Determined Cause 2 |
Software design |
Action |
A Product Notification letter dated July 2012, was sent to Siemens Healthcare Diagnostics. The letter suggested that an attached procedure should be followed for an server that requires the Century Break parameter change. If Siemens Healthcare Diagnostics has any questions about the procedure, the firm's representatives can contact the Sysmex Technical Assistance Center at 1-888-879-7639. A response form was also included with the letter requesting the Siemens Healthcare Diagnostics complete and return it.
A second Product Notification letter dated September 2012, was sent to Siemens Healthcare Diagnostics. The letter contained largely the same instructions as the July 2012, letter.
A third Product Notification letter dated March 2013, was sent to Siemens Healthcare Diagnostics. The letter include substantially similar instructions as the pervious letters; however, the procedure for changing the Century Break parameter was expanded. |
Quantity in Commerce |
214 units |
Distribution |
Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and the states of AL, AR, CA, CO, CT, FL, GA, HI, IA, IS, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA and WI and the country of 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 = LKM and Original Applicant = SYSMEX AMERICA, INC.
|
|
|
|