FDA Device recall Z-1100-2017
AutoDELFIA¿ Plate Processor , Fluorometer, for clinical use Product Number: 1235-5110 Product Usage: The Wallac 1235 AutoDELFIA automatic i…
- FDA Device
- Class III
- terminated
- Published 2017-02-01
On 2017-02-01 the FDA classified a Class III recall of AutoDELFIA¿ Plate Processor , Fluorometer, for clinical use Product Number: 1235-5110 Product Usage: The Wallac 1235 AutoDELFIA automatic i… by Perkinelmer Health Sciences, citing autoDELFIA System with Version 3.0 Software: Potential plate loading failures.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1100-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-12-21 |
| Published | 2017-02-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Perkinelmer Health Sciences |
| Distribution | US |
Product
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
Reason
AutoDELFIA System with Version 3.0 Software: Potential plate loading failures
Identifiers
| code_info | AutoDELFIA¿ Plate Processor 1235-5110 UDI:(01)06438147334766, (21)2352016 Serial Number: 2352016 (US) Serial Number…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1100-2017%22
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