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U.S. Department of Health and Human Services

Class 2 Device Recall Sysmex UF1000i Automated Urine Particle Analyzer with Urinalysis WAM

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 Class 2 Device Recall Sysmex UF1000i Automated Urine Particle Analyzer with Urinalysis WAMsee related information
Date Initiated by FirmMarch 31, 2013
Date PostedFebruary 10, 2014
Recall Status1 Terminated 3 on August 15, 2016
Recall NumberZ-0949-2014
Recall Event ID 65214
510(K)NumberK080887 
Product Classification Counter, urine particle - Product Code LKM
ProductThe 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 ContactSysmex 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
ActionA 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 Commerce214 units
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = LKM
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