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Siemens Healthcare Diagnostics recalls ADVIA 1800 System Software V2.01. Performs assays for general and specialty chemistries, methods for specific protein
Recalled November 27, 2013 · FDA recall Z-0345-2014 · Siemens Healthcare Diagnostics
Hazard
Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Behavior for All Software Versions utilized on ADVIA 1200, 1650, 1800 or 2400 Chemistry Systems. · FDA Class II
Units
1366 units
Sold at
Worldwide Distribution-USA (nationwide) and the countries of Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Vietnam.
Description
Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Behavior for All Software Versions utilized on ADVIA 1200, 1650, 1800 or 2400 Chemistry Systems.
Product
ADVIA 1800 System Software V2.01. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
Manufacturer(s)
Siemens Healthcare Diagnostics
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →