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

Recalled December 14, 2016 · FDA recall Z-0723-2017 · Siemens Healthcare Diagnostics

Hazard
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. · FDA Class II
Units
US: 23 systems; Foreign: 141 systems
Sold at
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.

Description

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

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

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