CLASS II Device recall · Reported 14 Dec 2016 · FDA Enforcement Report

Advia 560 Hematology Systems, Siemens Material Number recalled

Siemens Healthcare Diagnostics is recalling Advia 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD, distributed in 13 states. The recall was initiated on 21 Oct 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll serial numbers of ADVIA 560 Hematology Systems

Quantity recalledUS: 23 systems; Foreign: 141 systems

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0723-2017
FDA event ID: 75652
Recalling firm: Siemens Healthcare Diagnostics, Tarrytown, NY
Classification: Class II
Status: Terminated
Recall initiated: 21 Oct 2016
FDA classified: 8 Dec 2016
Reported: 14 Dec 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

21 Oct 2016	Recall initiated by company
8 Dec 2016	Classified by FDA	+48 days
14 Dec 2016	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

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.

California Colorado Florida Illinois Michigan New Jersey New York Ohio Puerto Rico Texas Washington Wisconsin Wyoming

Questions about this recall

Is Advia 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD recalled?

Yes. Siemens Healthcare Diagnostics recalled Advia 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD on 21 Oct 2016. The recall is Class II and its status is Terminated. Recall number Z-0723-2017.

Why was it recalled?

Which lots are affected?

All serial numbers of ADVIA 560 Hematology Systems

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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