Agency classClass IIIOur severity:Moderate FDA (Devices)·Z-1100-2017·Announced 2017-02-01

PerkinElmer AutoDELFIA Plate Processor Recalled for Potential Loading Failures

PerkinElmer is recalling AutoDELFIA Plate Processors with Version 3.0 software due to potential plate loading failures that could affect clinical assay results.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The hazard is a functional defect (plate loading failure) rather than a direct safety risk like fire or injury.

Plain-English summary

PerkinElmer Health Sciences, Inc. is recalling the AutoDELFIA Plate Processor, Fluorometer, for clinical use (Product Number: 1235-5110) equipped with Version 3.0 software. The recall is due to potential plate loading failures in the device.

The affected units were distributed worldwide, including nationwide in the United States (specifically Minnesota) and in China, India, the Philippines, France, South Korea, Vietnam, Taiwan, Morocco, Kazakhstan, the UK, Spain, and Israel. The recall includes one unit in the US and six units outside the US.

Healthcare facilities and users of the AutoDELFIA system should stop using the affected devices and contact PerkinElmer Health Sciences, Inc. for further instructions on the recall.

The recalled product

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…
Manufacturer: PerkinElmer Health Sciences, Inc.
Category: Medical Device — Laboratory Equipment
Hazard: functional-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

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

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by PerkinElmer Health Sciences, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · PerkinElmer Health Sciences, Inc.

See all →

Low
PerkinElmer 226 Sample Collection Device Recalled for Labeling Mismatch
FDA (Devices) · 2020-06-10
Low
PerkinElmer 226 Sample Collection Device Recalled for Labeling Mismatch
FDA (Devices) · 2017-08-02
Low
PerkinElmer AutoDELFIA System Recalled for Potential Plate Loading Failures
FDA (Devices) · 2017-02-01
Low
PerkinElmer AutoDELFIA System Recalled for Potential Plate Loading Failures
FDA (Devices) · 2017-02-01
Moderate
PerkinElmer Recalls Specimen Gate Laboratory Software Due to Disk Space Issue
FDA (Devices) · 2017-01-04

Same hazard · functional defect