FDAClass IIFebruary 1, 2017

cobas p 612 pre-analytical system recall

cobas p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping, Aliquotting and sorting of samples for analysis.

Why was it recalled?

The source record does not provide a concise hazard summary.

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?

Serial Number 63004316 63004416 63004516 63002816 63002916

Product
cobas p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping, Aliquotting and sorting of samples for analysis.
Recalling firm
Roche Diagnostics Corporation
Quantity
5
Distribution
TX and WA
Recall date
February 1, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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