FDAClass IISeptember 3, 2014

Siemens Dimension EXL Integrated Chemistry System in recall

Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes in human body fluids. All…

Why was Siemens Dimension EXL Integrated Chemistry System in recalled?

The Reagent Lid hinge may lose its effectiveness and slowly shift downward during maintenance procedures, potentially resulting in physical contact and injury to the operator.

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?

All Serial #s of material #s: 10636929, 10636928, 10486890, 10472176, 10639337, and 10639338

Product
Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes in human body fluids. All…
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
2757
Distribution
Nationwide and internationally, including Canada and Mexico
Recall date
September 3, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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