Recall Z-1102-2017
PerkinElmer Health Sciences, Inc. · initiated December 21, 2016
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
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
Codes / lots: Batch Code US: 18RXWD2, 18TYWD2 OUS: B901XD2,18WYWD2, 18RXWD2
Reason for recall
AutoDELFIA System with Version 3.0 Software: Potential plate loading failures
FDA-determined cause: Software design
Action taken
PerkinElmer issued letter on 12/21/16 to customers with AutoDELFIA Systems running version 3.0 Manager Software (revisons 1 and 2). The issue cannot be corrected by the customer therefore it is recommended the AutoDELFIA System be operated in the default English language variant until the AutoDELFIA Manager Software can be updated. The AutoDELFIA System with version 3.0 Manager Software performs as intended when the selected language variant is English. Customers are recommended to implement a software update to be deployed by PerkinElmer to resolve the issue. AutoDELFIA Manager Software version 3.0 revision 1 or 2 will be updated through the correction to revision 3 or the latest released revision
Details
- Recall number
- Z-1102-2017
- Initiated
- December 21, 2016
- Terminated
- October 3, 2018
- Product code
- KHO – Fluorometer, For Clinical Use
- 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,
- Recalling firm
- PerkinElmer Health Sciences, Inc., Waltham, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1100-2017 Class III | AutoDELFIA Plate Processor , Fluorometer, for clinical use Product Number: 1235-5110…AutoDELFIA System with Version 3.0 Software: Potential plate loading failures | 12/21/2016Terminated |
| Z-1101-2017 Class III | Program Update Package AutoDELFIA 3.0, Fluorometer, for clinical use Product Number:…AutoDELFIA System with Version 3.0 Software: Potential plate loading failures | 12/21/2016Terminated |