Company: Siemens Healthcare Diagnostics
Date of Enforcement Report: 11/27/2013
Class lI:
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.Recall Number Z-0343-2014, Z-0344-2014, Z-0345-2014, Z-0346-2014
REASON
iemens 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.
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Tarrytown, NY on 9/3/2013. Voluntary: Firm Initiated recall is ongoing.
DISTRIBUTION
Nationwide and Internationally
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