Class II — Sysmex America, Inc.
| Recalling firm | SYSMEX CORPORATION |
|---|---|
| Registered facility | View this company's 14 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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 |
| 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. |
| Quantity | 214 units |
| Distribution | 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. |
| Initiated | 2013-03-31 |
| Classified | 2014-02-10 |
| Terminated | 2016-08-15 |
| Recall number | Z-0949-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Sysmex America, Inc. (Z-0949-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65214/
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