Z-1101-2017 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 1, 2017
- Initiation Date
- December 21, 2016
- Termination Date
- October 3, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit (US) 2 units (OUS)
Product Description
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
Reason for Recall
AutoDELFIA System with Version 3.0 Software: Potential plate loading failures
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,
Code Information
Batch Code: 649552 OUS: 649552, 649552