Events

Recall of Device Recall Sysmex UF1000i Automated Urine Particle Analyzer with Urinalysis WAM

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sysmex America, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    65214
  • Event Risk Class
    Class 2
  • Event Number
    Z-0949-2014
  • Event Initiated Date
    2013-03-31
  • Event Date Posted
    2014-02-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118288
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Counter, urine particle - Product Code LKM
  • Reason
    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.
  • 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.

Device

Device Recall Sysmex UF1000i Automated Urine Particle Analyzer with Urinalysis WAM
  • Model / Serial
    Software versions 1.0, 1.01, 1.1.1, 1.1.2
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    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.
  • Manufacturer
    Sysmex America, Inc.

Manufacturer

Sysmex America, Inc.
  • Manufacturer Address
    Sysmex America, Inc., 1 Nelson C White Pkwy, Mundelein IL 60060-9528
  • Manufacturer Parent Company (2017)
    Sysmex Corp.
  • Source
    USFDA