Z-0949-2014Class II

The UF-1000i is a fully automated urine particle analyzer intended for vitro diagnostic use in urinalysis...

Name: Z-0949-2014 The UF-1000i is a fully automated urine particle analyzer intended for vitro diagnostic use in urinalysis...
Creator: Sysmex America, Inc.
Published: 2013-03-31
License: https://open.fda.gov/license/

Sysmex America, Inc. / initiated 2013-03-31 / Terminated / root cause: software

FDA source

Sysmex America, Inc. began a recall of The UF-1000i is a fully automated urine particle analyzer intended for vitro diagnostic use in urinalysis. The instrument can perform screening for abnormal... on 2013-03-31. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0949-2014
Classification: Class II
Status: Terminated
Initiated: 2013-03-31
Posted: 2014-02-10
Terminated: 2016-08-15
Recalling firm: Sysmex America, Inc.
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.
Product code: LKM Counter, Urine Particle
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
Root cause tag: software
FDA root cause: 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.
Product codes and lots: Software versions 1.0, 1.01, 1.1.1, 1.1.2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0949-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0949-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-19	2014-02-10

Product code LKM

K080887Class IISysmex Uf-1000I, Automated Urine Particle Analyzer with Urinalysis Wam SoftwareSysmex America, Inc. / cleared 2008-05-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)