FDAClass IIDecember 19, 2012

LightCycler 1.2 recall: Software Issue

LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well…

Why was LightCycler 1.2 recalled?

Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.

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?

Device-associated diagnostic software

Product
LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well…
Recalling firm
Roche Molecular Systems, Inc.
Quantity
3,772 units
Distribution
Nationwide Distribution
Recall date
December 19, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
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