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Recall Observatory FDA recall evidence

Device product

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.

Z-0011-2014

August 12, 2013

Class II

Product summary

Firm
Siemens Healthcare Diagnostics
Event
Event 65898
Status
Terminated
Classification
Class II
Quantity
311 units total (US: 51 units; Foreign: 260 units)
Official record key
device-enforcement:Z-0011-2014

Official wording

Reason: 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.

Code information: All serial numbers connected to the ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.