FDA Enforcement
Class III
Terminated
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
Recall: Z-1102-2017
·
Reported February 1, 2017
Enforcement
- Recall Number
- Z-1102-2017
- Event ID
- 75949
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- PerkinElmer Health Sciences, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 1, 2017
- Initiation Date
- December 21, 2016
- Classification Date
- January 26, 2017
- Termination Date
- October 3, 2018
- Address
- 940 Winter St, N/A, Waltham, MA, 02451-1457, United States
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
AutoDELFIA System with Version 3.0 Software: Potential plate loading failures
Code Info
Batch Code US: 18RXWD2, 18TYWD2 OUS: B901XD2,18WYWD2, 18RXWD2
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,
Quantity
1 US ; 3 OUS