Sysmex UF-1000i Urine Analyzer Recalled for Software Date Calculation Error
Sysmex America is recalling 214 UF-1000i urine analyzers because a software patch error prevented proper database file purging, causing system performance issues.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a software defect causing system performance issues (database capacity limits) rather than direct physical injury or death, fitting the criteria for a moderate severity recall involving low-risk operational defects.
Plain-English summary
Sysmex America, Inc. is recalling 214 units of the UF-1000i fully automated urine particle analyzer. The device is intended for in vitro diagnostic use in urinalysis to screen for abnormal samples in laboratories. The recall affects software versions 1.0, 1.01, 1.1.1, and 1.1.2.
The recall was initiated because 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. This mismatch prevented the software from properly calculating a purge date for database files based on customer data retention settings. As a result, database files reached their maximum capacity, causing system performance issues.
The affected units were distributed nationwide in the United States, including Puerto Rico, and in Canada. The distribution covered numerous states including 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. Users should contact Sysmex America for further instructions regarding the software update.
The recalled product
- 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.
- Manufacturer
- Sysmex America, Inc.
- Affected units
- 214
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Software versions 1.0
- 1.01
- 1.1.1
- 1.1.2
Distribution
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