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Recall Observatory FDA recall evidence

Device 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.

Z-0949-2014

March 31, 2013

Class II

Product summary

Firm
Sysmex America, Inc.
Event
Event 65214
Status
Terminated
Classification
Class II
Quantity
214 units
Official record key
device-enforcement:Z-0949-2014

Official wording

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

Code information: Software versions 1.0, 1.01, 1.1.1, 1.1.2

Distribution pattern: 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.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software could