FDAClass IIIApril 10, 2013

Siemens Dimension(R) EXL(TM) LM STM recall

Siemens Dimension(R) EXL(TM) LM STM (Siemens Material Number 106393377). Intended to measure a variety of analytes in human body fluids.

Why was Siemens Dimension(R) EXL(TM) LM STM recalled?

Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an increase in System Check failures due to high System Check LOCI results. Upon further investigation, Siemens has determined that many of these errors are due to the current limit set for System Check LOCI results. The errors have no impact on results, but they may cause customer inconvenience. Siemens h

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?

Siemens Material Number 106393377

Product
Siemens Dimension(R) EXL(TM) LM STM (Siemens Material Number 106393377). Intended to measure a variety of analytes in human body fluids.
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
2207 total
Distribution
Worldwide Distribution.
Recall date
April 10, 2013
Classification
Class III
Status
Terminated
Agency
FDA (device)
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