Sysmex America, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0949-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 31, 2013

Date Posted: February 19, 2014

Recall Number: Z-0949-2014

Event ID: 65214

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

Status: Terminated

Product Quantity: 214 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated