PerkinElmer Health Sciences, Inc. recalls Program Update Package AutoDELFIA¿ 3.0, Fluorometer, for clinical use Product Number: 1235-8110 Product Usage: The Wall…

Recall date

December 21, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1101-2017

FDA classification

Class III

Brand / firm

PerkinElmer Health Sciences, Inc.

Sold / distributed

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,

Why it was recalled

AutoDELFIA System with Version 3.0 Software: Potential plate loading failures

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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