Z-2114-2013Class II

ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . The ADVIA 120 is a hematology...

Name: Z-2114-2013 ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . The ADVIA 120 is a hematology...
Creator: Siemens Healthcare Diagnostics
Published: 2013-06-26
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-06-26 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics began a recall of ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . The ADVIA 120 is a hematology system that utilizes the principles of flow cytometry... on 2013-06-26. FDA classified it as Class II and gives the reason as "The ADVIA 120 optics cover or hood is located on the very top of the ADVIA 120 analyzer. When the optics cover is raised, it is supported by two gas struts (SMN 10309266) attached to the cover on the left and right...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2114-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-26
Posted: 2013-08-28
Terminated: 2017-02-28
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . The ADVIA 120 is a hematology system that utilizes the principles of flow cytometry in order to provide complete blood counts.
Product code: GKL Counter, Cell, Automated (Particle Counter)
Reason for recall: The ADVIA 120 optics cover or hood is located on the very top of the ADVIA 120 analyzer. When the optics cover is raised, it is supported by two gas struts (SMN 10309266) attached to the cover on the left and right sides. Over time, it is possible that these struts may lose their effectiveness and fail to support the optics cover in the open position. This could cause the cover to fall during maintenance procedures.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Siemens sent an Urgent Device Correction Letter dated June 26, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed of the ADVIA 120 system displays a problem when raising and supporting the optics cover, immediately contact your service provider to arrange to have the cover struts serviced. If the optics cover will not stay in the up position, as required, do not perform maintenance procedures on the optics area until the hood struts have been replaced. Siemens field support will be proactively replacing the optics cover hood struts on a regular preventive maintenance cycle based on the age of the system. Please forward this notification to whomever you may have distributed this product We apologize for the inconvenience that this situation has caused. Thank you for your patience and continued support. This response form is to confirm receipt of the enclosed Siemens Healthcare Diagnostics Urgent Device Correction dated June 2013 regarding Optics Cover Struts (SMN 10309266). Please read each question and indicate the appropriate answer. Fax this completed form to Siemens Healthcare diagnostics at the fax number indicated at the bottom of this page. PLEASE FAX THIS COMPLETED FORM TO THE TECHNICAL SOLUTIONS CENTER AT (302) 631-7597.
Quantity in commerce: Domestic: 950 units; Foreign: 3369 units
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Austria, Australia, Belgium, Bosnia - Herzegovina, China, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, Iceland, India, Indonesia, Ireland, Iraq, Israel, Italy, Japan, Kenya, Republic of Korea, Kuwait, Lebanon, Lithuania, Luxembourg, Martinique, Malaysia, Netherlands, Norway, New Zealand, Philippines, Poland, Portugal, Romania, Russian Republic, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom and Vietnam.
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2114-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2114-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-28

Product code GKL

K971998Class IIAdvia 120 Hematology System, in Vitro Diagnostic SystemBayer Corp. / cleared 1997-08-29

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)