Recall Z-1102-2017 ยท KHO Fluorometer, For Clinical Use
PerkinElmer Health Sciences, Inc.
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
| Date | Dec 21, 2016 |
| Status | Terminated |
| Reason | AutoDELFIA System with Version 3.0 Software: Potential plate loading failures |
| Root cause | Software design |
| Action | 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 versi |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K935047 | AUTO DELFIA Wallac OY, May 23, 1994 |