FDA Device recall Z-0949-2014
The UF-1000i is a fully automated urine particle analyzer intended for vitro diagnostic use in urinalysis
- FDA Device
- Class II
- terminated
- Published 2014-02-19
On 2014-02-19 the FDA classified a Class II recall of The UF-1000i is a fully automated urine particle analyzer intended for vitro diagnostic use in urinalysis by Sysmex America, citing 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 sof….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0949-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-31 |
| Published | 2014-02-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Sysmex America |
| Distribution | US |
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
Identifiers
| code_info | Software versions 1.0, 1.01, 1.1.1, 1.1.2 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0949-2014%22
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