Recall Z-0949-2014
Sysmex America, Inc. · initiated March 31, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Software versions 1.0, 1.01, 1.1.1, 1.1.2
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: Software design
Action taken
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.
Details
- Recall number
- Z-0949-2014
- Initiated
- March 31, 2013
- Posted by FDA
- February 10, 2014
- Terminated
- August 15, 2016
- Product code
- LKM – Counter, Urine Particle
- Quantity
- 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.
- Recalling firm
- Sysmex America, Inc., Mundelein, IL