19

Feb

2014

Sysmex UF-1000i Cl II

0

Company:Sysmex America Inc
Date of Enforcement Report:2/19/2014
Class lI:

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.
Recall Number Z-0949-2014

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 performance issues..

RECALLING FIRM/MANUFACTURER
Sysmex America, Inc., Mundelein IL on 3/31/2013. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
214 units

DISTRIBUTION
Nationwide, Puerto Rico and Canada

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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