Z-0723-2017Class II

ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD

Name: Z-0723-2017 ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2016-10-21
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-10-21 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD on 2016-10-21. FDA classified it as Class II and gives the reason as "Siemens is investigating an issue which may cause an incorrect result to be reported. Siemens received two reports of multiple discordant records for the same Sample ID in the ADVIA 560 Hematology System database that...". 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-0723-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-21
Posted: 2016-12-08
Terminated: 2018-06-07
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.
Product code: GKZ Counter, Differential Cell
Reason for recall: Siemens is investigating an issue which may cause an incorrect result to be reported. Siemens received two reports of multiple discordant records for the same Sample ID in the ADVIA 560 Hematology System database that occurred during the installation of the systems. The database should only contain one record of a Sample ID number for any given time and date. If there are multiple records for the same Sample ID, it is possible that multiple results may be manually or automatically sent to the Laboratory Information System (LIS), printed or displayed on the results report screen.
Root cause tag: software
FDA root cause: Software design
Action: An Urgent Medical Device Correction Letter HI17-02.A.US (dated October 21, 2016) and Response Form were sent to US Customers via Federal Express. An Urgent Field Safety Notice was sent to customers outside the US on October 21, 2016, (distribution is determined at the country level). The letters instruct customers to contact their local Siemens technical support representative if they obtain multiple results for one Sample ID. It also informs the customer what to do if the ADVIA 560 Hematology System generates any of the six error messages listed in the letter. For further questions, please call (312) 275-7795.
Quantity in commerce: US: 23 systems; Foreign: 141 systems
Distribution: Worldwide Distribution - US Distribution to the states of including Puerto Rico and : CA, CO, FL, IL, MI, NJ, NY, OH, TX, WA, WI, WI and WY., and to the countries of : Angola, Australia, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Egypt, France, Germany, Greece, India, Italy, Japan, Kenya, Malaysia, Mexico, Myanmar, Netherlands, Norway, Pakistan, Portugal, Saudi Arabia, Slovenia, Spain, Switzerland, Turkey, Uganda, United Kingdom, Vietnam.
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-0723-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0723-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-14	2016-12-08

Product code GKZ

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)