Z-1500-2016Class II

ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD The ADVIA 560 Hematology System is...

Name: Z-1500-2016 ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD The ADVIA 560 Hematology System is...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2016-03-10
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-03-10 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD The ADVIA 560 Hematology System is a fully-automated, high-quality hematology system... on 2016-03-10. FDA classified it as Class II and gives the reason as "Software anomaly; Siemens identified that software version 1.4.2133 on the ADVIA 560 Hematology System does not trigger the following flags: The G or L morphology flags for immature granulocytes (IG) and atypical...". 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-1500-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-10
Posted: 2016-04-20
Terminated: 2018-06-07
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD The ADVIA 560 Hematology System is a fully-automated, high-quality hematology system for in vitro diagnostic use in clinical laboratories
Product code: GKZ Counter, Differential Cell
Reason for recall: Software anomaly; Siemens identified that software version 1.4.2133 on the ADVIA 560 Hematology System does not trigger the following flags: The G or L morphology flags for immature granulocytes (IG) and atypical lymphocytes (ATYP), respectively. The results from patient samples which have immature granulocytes or atypical lymphocytes will not generate the flags when they should. As defined in t
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Siemens sent an Urgent Medical Device Correction Letter dated March 11, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. .Actions to be Taken by the Customer: To ensure that the patient sample amount for processing is met, follow the requirements for the amount of sample required in the ADVIA 560 Hematology System Operators Guide. Review all patient results for abnormal white blood cell results and process as defined by your lab criteria for abnormal samples and confirm using manual differentials as needed. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. Please review this letter with your Medical Director. Your Siemens Customer Service Engineer will contact you to schedule time for installation of the 1.4.2333 software when it is available. Please retain this letter with your laboratory records, and forward this letter to those who may have received this product. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative. For further questions, please call (312) 275-7795.
Quantity in commerce: US: 8 systems; Foreign: 64 systems
Distribution: Worldwide Distribution - US Distribution including Puerto Rico and to the states of : California, Illinois, Washington and Wisconsin., and to the countries of : Angola, Austria, Canada, Chile, Colombia, Czech Republic, France, Germany, India, Italy, Kenya, Netherlands, Norway, Portugal, Singapore, Slovenia, Spain, Turkey, Uganda and United Kingdom.
Product codes and lots: All serial numbers of ADVIA 560 Hematology Systems.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1500-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1500-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-27	2016-04-20

Product code GKZ

K111534Class IIAbacus 3CpDiatron U.S., Inc. / cleared 2012-08-02

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)