Agency classClass IIIOur severity:Low FDA (Devices)·Z-1101-2017·Announced 2017-02-01

PerkinElmer AutoDELFIA System Recalled for Potential Plate Loading Failures

PerkinElmer is recalling AutoDELFIA systems 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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or minor issues.

Plain-English summary

PerkinElmer Health Sciences, Inc. is recalling the AutoDELFIA System with Version 3.0 software. The recall is due to potential plate loading failures in the automatic immunoassay system. The affected product is the Program Update Package AutoDELFIA 3.0, Fluorometer, for clinical use, Product Number 1235-8110.

The recall involves 1 unit in the United States and 2 units outside the United States. The product was distributed worldwide, including in the state of Minnesota and in China, India, the Philippines, France, South Korea, Vietnam, Taiwan, Morocco, Kazakhstan, the UK, Spain, and Israel. The batch code for the affected units is 649552.

This is a Class III recall, which indicates that the violation is not likely to cause adverse health consequences. Users of the AutoDELFIA system should contact PerkinElmer Health Sciences for further instructions on how to address the potential plate loading failures.

The recalled product

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

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 (2)

Batch Code: 649552 OUS: 649552
649552

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.

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Moderate
PerkinElmer AutoDELFIA Plate Processor Recalled for Potential Loading Failures
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PerkinElmer AutoDELFIA System Recalled for Potential Plate Loading Failures
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Same hazard · malfunction