Z-0949-2014 Class II Terminated
FDA device recall Z-0949-2014 was initiated by Sysmex America, Inc. on March 31, 2013 and is designated Class II. 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 prope… The recall status is terminated (terminated August 15, 2016). Affected quantity: 214 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 19, 2014
- Initiation Date
- March 31, 2013
- Termination Date
- August 15, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 214 units
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
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.
Code Information
Software versions 1.0, 1.01, 1.1.1, 1.1.2