Siemens Healthcare Diagnostics: Medical Device Recall in 2013 - (Recall #: Z-0011-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: August 12, 2013

Date Posted: October 23, 2013

Recall Number: Z-0011-2014

Event ID: 65898

Reason for Recall:

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.

Status: Terminated

Product Quantity: 311 units total (US: 51 units; Foreign: 260 units)

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.

Voluntary or Mandated:

Voluntary: Firm initiated