FDAClass IIFebruary 19, 2014

Siemens ADVIA Chemistry Systems recall: Software Issue

Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 Product Usage: The ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 (also…

Why was Siemens ADVIA Chemistry Systems recalled?

The ADVIA Chemistry software systems using certain software versions allows the system to automatically run assay calibrations and quality control (QC).

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?

ADVIA 1200 V2.00 - 10386841 ADVIA 1200 V2.01 - 10469445 ADVIA 1650 V3.52 - 10318424 ADVIA 1650 V4.01 - 10285281 ADVIA 1800 V2.01 - 10639244 ADVIA 2400 V4.01 - 10639265

Product
Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 Product Usage: The ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 (also…
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
3759
Distribution
Worldwide Distribution and USA Nationwide.
Recall date
February 19, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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