Home / Recalls / Medical Devices
Siemens Healthcare Diagnostics recalls ADVIA 1200 System Software: 1) V2.00, 2) V2.01. Performs assays for general and specialty chemistries, methods for sp
Recalled November 27, 2013 · FDA recall Z-0343-2014 · 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
625 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 1200 System Software: 1) V2.00, 2) 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 →