Reported Oct 23, 2013 · Terminated

ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 ---…

Siemens Healthcare Diagnostics

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Siemens Healthcare Diagnostics · 511 Benedict Ave · Tarrytown, NY · 10591-5005

Is this the product you have?

  • ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and
  • SMN 10361798 --- CLASSIFICATION NAMECounter, Differential Cell, Automated (Particle Counter) The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry in order to provide complete blood counts
Lot codes and dates
  • All serial numbers connected to the ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide.
Amount recalled
311 units total (US: 51 units; Foreign: 260 units)

Where it was sold

  • Nationwide

Why it was recalled

Siemens determined that if an autosampler rack jam error occurs during operation of an ADVIA 2120/2120i connected to an ADVIA Autoslide, it is possible that the next slide processed by the Autoslide could be labeled with the wrong sample identification information.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 18, 2015 · Data as of Sep 19, 6:16 PM UTC

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