Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1500-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: March 10, 2016

Date Posted: April 27, 2016

Recall Number: Z-1500-2016

Event ID: 73588

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

Status: Terminated

Product Quantity: US: 8 systems; Foreign: 64 systems

Code Information:

All serial numbers of ADVIA 560 Hematology Systems.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated