AutoDELFIA Plate Processor , Fluorometer, for clinical use recallZ-1100-2017 · PerkinElmer Health Sciences, Inc. · initiated Dec 21, 2016
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from PerkinElmer Health Sciences, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
AutoDELFIA System with Version 3.0 Software: Potential plate loading failures
FDA root cause category: Software design
What the company is doing
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
Recall details
- Recall number
- Z-1100-2017
- Status
- Terminated
- Initiated by the company
- Dec 21, 2016
- Recalling firm
- PerkinElmer Health Sciences, Inc.
- Quantity
- 1 unit (US) 6 (OUS)
- Product code
- KHO
- FDA submissions
- K935047
- 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,
Product description
AutoDELFIA Plate Processor , Fluorometer, for clinical use Product Number: 1235-5110 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
Code information (models, lots, serial numbers)
AutoDELFIA¿ Plate Processor 1235-5110 UDI:(01)06438147334766, (21)2352016 Serial Number: 2352016 (US) Serial Numbers: OUS: s/n: 2352014, 2352046, 2352048,2352054, 2352056, 2352059
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- AutoDELFIA Plate processor 1235-0110Wallac Oy · Fluorometer, For Clinical Use1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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