Recall Z-0346-2014— Siemens Healthcare Diagnostics
Class II · Terminated
Class II FDA medical device recall by Siemens Healthcare Diagnostics, initiated 2013-09-03, terminated 2017-03-07. FDA's recall record names no specific 510(k) clearance for this event. Product: ADVIA 2400 System Software V4.01. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.. Reason: 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..
- Recalling firm
- Siemens Healthcare Diagnostics
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-09-03
- Terminated
- 2017-03-07
- Firm location
- Tarrytown, NY, United States
Product description
ADVIA 2400 System Software V4.01. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.