Z-1100-2017 Class III Terminated
FDA device recall Z-1100-2017 was initiated by PerkinElmer Health Sciences, Inc. on December 21, 2016 and is designated Class III. Reason for recall: AutoDELFIA System with Version 3.0 Software: Potential plate loading failures The recall status is terminated (terminated October 3, 2018). Affected quantity: 1 unit (US) 6 (OUS).
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) 6 (OUS)
Product Description
AutoDELFIA¿ Plate Processor , Fluorometer, for clinical use Product Number: 1235-5110 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
AutoDELFIA¿ Plate Processor 1235-5110 UDI:(01)06438147334766, (21)2352016 Serial Number: 2352016 (US) Serial Numbers: OUS: s/n: 2352014, 2352046, 2352048,2352054, 2352056, 2352059