FDAClass IIJuly 8, 2015

CentraLink" Data Management System recall

CentraLink" Data Management System; software is a network solution provider and multi-system data manager for the instruments and lab automation…

Why was CentraLink" Data Management System recalled?

Siemens Healthcare Diagnostics has determined that the sample query function that includes Instrument or Instrument Group as search criteria may not return all samples from the Dimension Vista systems if onboard aliquot support rules are configured in the CentraLink system.

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?

Product: Siemens CentraLink Data Management System, v14.0.5 Material Number (SMN)10811741, 10811742, 10811743, 10814298, 10814877, 10814880,10814881, Product: CentraLink Data Management System, v14.0.8 Material Number (SMN)10815474, 10816519, 10816520, 10816521, 10816522, 10816523, 10816524, 10817180, 10817181

Product
CentraLink" Data Management System; software is a network solution provider and multi-system data manager for the instruments and lab automation…
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
1941
Distribution
Worldwide Distribution - Nationwide Distribution and to the countries of : Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Netherlands, Saudi Arabia, Spain, Switzerland and United Kingdom.
Recall date
July 8, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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