Z-0011-2014Class II

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

Name: Z-0011-2014 ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798...
Creator: Siemens Healthcare Diagnostics
Published: 2013-08-12
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-08-12 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics began a recall of ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell... on 2013-08-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0011-2014
Classification: Class II
Status: Terminated
Initiated: 2013-08-12
Posted: 2013-10-17
Terminated: 2015-11-18
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: GKZ Counter, Differential Cell
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.
Root cause tag: software
FDA root cause: Software design
Action: Siemens sent an Urgent Medical Device Correction Letter dated August 8, 2013, and Effectiveness Checks Forms were sent to customers on August 12, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised if they do not have an ADVIA Autoslide connected to their system, no action is required. To avoid the possibility of mislabeling a slide when an ADVIA 2120/2120i rack jam error occurs: Eject the sample rack. Troubleshoot and correct the reason for the rack jam error. Rerun the sample rack. Field service personnel were sent a support bulletin describing the issue and instructing them how to deal with customer questions. If you need additional assistance, please contact Global Product Support Tarrytown, New York @ [email protected]
Quantity in commerce: 311 units total (US: 51 units; Foreign: 260 units)
Distribution: 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.
Product codes and lots: All serial numbers connected to the ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0011-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0011-2014	Class II	Terminated	Voluntary: Firm initiated	2013-10-23	2013-10-17

Product code GKZ

K102644Class IIAdvia 2120 with Autoslide System, and Advia 2120ISiemens Healthcare Diagnostics / cleared 2011-11-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)