FDA Device recall Z-1101-2017
Program Update Package AutoDELFIA¿ 3.0, Fluorometer, for clinical use Product Number: 1235-8110 Product Usage: The Wallac 1235 AutoDELFIA a…
- FDA Device
- Class III
- terminated
- Published 2017-02-01
On 2017-02-01 the FDA classified a Class III recall of Program Update Package AutoDELFIA¿ 3.0, Fluorometer, for clinical use Product Number: 1235-8110 Product Usage: The Wallac 1235 AutoDELFIA a… 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-1101-2017 |
| 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
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
Reason
AutoDELFIA System with Version 3.0 Software: Potential plate loading failures
Identifiers
| code_info | Batch Code: 649552 OUS: 649552, 649552 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1101-2017%22
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