FDAClass IIIFebruary 1, 2017

DELFIA¿ PC with V3.0 Software recall: Software Issue

DELFIA¿ PC with V3.0 Software, Fluorometer, for clinical use Product Number: 1235-8100 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay…

Why was DELFIA¿ PC with V3.0 Software recalled?

AutoDELFIA System with Version 3.0 Software: Potential plate loading failures

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Batch Code US: 18RXWD2, 18TYWD2 OUS: B901XD2,18WYWD2, 18RXWD2

Product
DELFIA¿ PC with V3.0 Software, Fluorometer, for clinical use Product Number: 1235-8100 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay…
Recalling firm
PerkinElmer Health Sciences, Inc.
Quantity
1 US ; 3 OUS
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,
Recall date
February 1, 2017
Classification
Class III
Status
Terminated
Agency
FDA (device)
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