Reported Feb 19, 2014 · Terminated
The UF-1000i is a fully automated urine particle analyzer intended for vitro diagnostic use in urinalysis. The…
Sysmex America, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sysmex America, Inc. · 1 Nelson C White Pkwy · Mundelein, IL · 60060-9528
Is this the product you have?
- 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.
- Lot codes and dates
Software versions 1.01.011.1.11.1.2
- Amount recalled
- 214 units
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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