FDAFDA · Food and drugs·Recall number Z-0011-2014
ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, 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.
Published October 23, 2013 · Recall initiated: August 12, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics
- Distributor
- Worldwide Distribution - USA (nationwide) and the countries of Australia, Austria, Belgium, Canada, Croatia, Denmark, France, Germany, Greece, Italy, Japan, Malaysia, Netherlands, Norway, Philippines, Portugal, South Korea, Singapore, Slovenia, Spain, Switzerland, Thailand, Turkey, United Kingdom and Vietnam.
- Lot
- All serial numbers connected to the ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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