Recall Z-0949-2014— Sysmex America, Inc.

Name: FDA recall Z-0949-2014
Creator: U.S. Food and Drug Administration
Published: 2013-03-31

Class II · Terminated

Class II FDA medical device recall by Sysmex America, Inc., initiated 2013-03-31, terminated 2016-08-15. It names one FDA 510(k) clearance: K080887. 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.. 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.

Recalling firm: Sysmex America, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-03-31
Terminated: 2016-08-15
Firm location: Mundelein, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K080887 — SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARESysmex America, Inc.·cleared 2008-05-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.