PerkinElmer Health Sciences, Inc.: AutoDELFIA¿ Plate Processor , Fluorometer, for clinical use Product Number: 1235-5110 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is desig

Is my product affected?

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 tim

• UPC 06438147334766

Check against the official notice below — it lists the full affected range.

What happened

PerkinElmer Health Sciences is recalling the Wallac 1235 AutoDELFIA automatic immunoassay system (Product Number 1235-5110) due to potential plate loading failures in units running Version 3.0 Software. One unit was distributed in Minnesota in the United States, and six units were distributed outside the US in China, India, Philippines, France, South Korea, Vietnam, Taiwan, Morocco, Kazakhstan, UK, Spain, and Israel.

The record does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

AutoDELFIA System with Version 3.0 Software: Potential plate loading failures

Details from the source

Reason for recall: AutoDELFIA System with Version 3.0 Software: Potential plate loading failures 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, Quantity: 1 unit (US) 6 (OUS) Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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