FDAClass IIMay 9, 2018

Atellica Solution and Atellica Sample Handler Prime for recall

Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens.

Why was Atellica Solution and Atellica Sample Handler Prime for recalled?

When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers

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?

UDI 00630414002439

Product
Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens.
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
N/A
Distribution
FL and France Spain Sweden United Kingdom Germany
Recall date
May 9, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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