PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: December 14, 2016 Initiated: October 21, 2016 #Z-0723-2017

Product Description

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

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.

Details

Units Affected
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.
Location
Tarrytown, NY

Frequently Asked Questions

What product was recalled? ▼
ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: US: 23 systems; Foreign: 141 systems.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 14, 2016. Severity: Moderate. Recall number: Z-0723-2017.

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