FDA Enforcement
Class II
Terminated
ADVIA 1650 System Software: 1) V4.01, 2) V3.52. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
Recall: Z-0344-2014
·
Reported November 27, 2013
Enforcement
- Recall Number
- Z-0344-2014
- 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 1650 System Software: 1) V4.01, 2) V3.52. 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) 10318424, 2) 10285281
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Vietnam.
Quantity
892 units