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
FDA Recall Z-1101-2017 · Posted None
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Recalling FirmPerkinElmer Health Sciences, Inc.
Recall StatusTerminated
Product CodeKHO
Date Initiated2016-12-21
Date Terminated2018-10-03
Product Quantity1 unit (US) 2 units (OUS)
Reason for Recall
AutoDELFIA System with Version 3.0 Software: Potential plate loading failures
Firm 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 version 3.0 revision 1 or 2 will be updated through the correction to revision 3 or the latest released revision
Root Cause
Software design
Distribution Pattern
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,
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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