DELFIA¿ PC with V3.0 Software, Fluorometer, for clinical use Product Number: 1235-8100 Produ...

FDA Recall #Z-1102-2017 — Class III — December 21, 2016

Recall #Z-1102-2017 Date: December 21, 2016 Classification: Class III Status: Terminated

Product Description

DELFIA¿ PC with V3.0 Software, Fluorometer, for clinical use Product Number: 1235-8100 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 US ; 3 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 US: 18RXWD2, 18TYWD2 OUS: B901XD2,18WYWD2, 18RXWD2

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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