The UF-1000i is a fully automated urine particle analyzer intended… — Class II medical device recall Z-0949-2014
Terminated recall by Sysmex America, Inc., reported 2014-02-19, distributed nationwide. The current Century Break patch did not contain the same setting for the Century Break year for both the Red H
| Recall number | Z-0949-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sysmex America, Inc., Mundelein, IL, United States |
| Recall initiated | 2013-03-31 |
| Classified | 2014-02-10 |
| Reported by FDA | 2014-02-19 |
| Terminated | 2016-08-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 214 units |
| Reason classes | device malfunction, software |
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 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0949-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.