Siemens Healthcare Diagnostics, Inc. recalls ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.

Recall date

October 21, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0723-2017

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics, Inc.

Sold / 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,…

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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