FDA Enforcement
Class II
Terminated
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: Z-0343-2014
·
Reported November 27, 2013
Enforcement
- Recall Number
- Z-0343-2014
- Event ID
- 66069
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Siemens Healthcare Diagnostics
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 27, 2013
- Initiation Date
- September 3, 2013
- Classification Date
- November 18, 2013
- Termination Date
- March 7, 2017
- Address
- 511 Benedict Ave, Tarrytown, NY, 10591-5005, United States
Description
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.
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.
Code Info
Product Codes: 1) 10386841, 2) 10469445
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Vietnam.
Quantity
625 units