Device product
Program Update Package AutoDELFIA¿ 3.0, Fluorometer, for clinical use Product Number: 1235-8110 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven and widely used method of time resolved fluorometry
Z-1101-2017
Product summary
- Event
- Event 75949
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1 unit (US) 2 units (OUS)
- Official record key
device-enforcement:Z-1101-2017
Official wording
Reason: AutoDELFIA System with Version 3.0 Software: Potential plate loading failures
Code information: Batch Code: 649552 OUS: 649552, 649552
Distribution pattern: Worldwide Distribution - US Nationwide in the state of MN and countries of China, India, Philippines, France, South Korea, Vietnam, Taiwan, Morocco, Kazachstan, UK, Spain, and Israel,
Derived failure modes
-
Unknown
AutoDELFIA System with Version 3.0 Software: Potential plate loading failures