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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Software versions 1.0, 1.01, 1.1.1, 1.1.2
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Sysmex America, Inc.
- 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
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
Software versions 1.0, 1.01, 1.1.1, 1.1.2
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0949-2014
Related Recalls
Sysmex was made aware of a report of false results due to carry-over caused by the sporadic omission of the probe wash step during antibody pipetting on the PS-10 Sample Preparation System.
Insufficient amount of antibody without an error message or alarm
Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers.
Sysmex America
When excessive amounts of urine spills on the rack transport track and reaches the electrical components of the CV-11 conveyor, there is a potential for smoke and/or sparks which may present a combustion hazard.