Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The UF-1000i is a fully automated urine particle analyzer intended Recalled by Sysmex America, Inc. Due to The current Century Break patch did not contain...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Sysmex America, Inc. directly.
Affected Products
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
Why Was This 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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sysmex America, Inc.
Sysmex America, Inc. has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report