Program Update Package AutoDELFIA¿ 3.0, Fluorometer, for clinical use Product Number: 1235-8110 ...
FDA Recall #Z-1101-2017 — Class III — December 21, 2016
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
Recalling Firm
PerkinElmer Health Sciences, Inc. — Waltham, MA
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
1 unit (US) 2 units (OUS)
Distribution
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated