FDAClass IINovember 2, 2016

cobas 6000 Series system c6000 recall

cobas 6000 Series system c6000, Chemistry (Photometric, Discrete), for clinical Use. Modular e601: Immunoassay Analyzer Product Usage: The cobas…

Why was cobas 6000 Series system c6000 recalled?

Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.

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?

Not applicable

Product
cobas 6000 Series system c6000, Chemistry (Photometric, Discrete), for clinical Use. Modular e601: Immunoassay Analyzer Product Usage: The cobas…
Recalling firm
Roche Diagnostics Operations, Inc.
Quantity
9014 in total
Distribution
US Nationwide Distribution
Recall date
November 2, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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