Recall Z-0344-2014
Siemens Healthcare Diagnostics · initiated September 3, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Product Codes: 1) 10318424, 2) 10285281
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.
FDA-determined cause: Software design
Action taken
On September 3, 2013, Siemens Healthcare Diagnostics issued an Urgent Field Safety Notice for the ADVIA 1200, 1650, 1800 and 2400 Chemistry Systems due to a software issue. The software issue has caused the Chemistry Systems to generate reports without error flags. Notices were sent to domestic customers via U.S. and outside the US the distribution is determined at the country level. The customers were instructed to contact Siemens Healthcare Diagnostics Technical Solution Center if they have technical questions regarding this issue at 877-229-3711 (prompt 18).
Details
- Recall number
- Z-0344-2014
- Initiated
- September 3, 2013
- Posted by FDA
- November 18, 2013
- Terminated
- March 7, 2017
- Product code
- JGS – Electrode, Ion Specific, Sodium
- Quantity
- 892 units
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Vietnam.
- Recalling firm
- Siemens Healthcare Diagnostics, Tarrytown, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0343-2014 Class II | ADVIA 1200 System Software: 1) V2.00, 2) V2.01. Performs assays for general and…Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging… | 09/03/2013Terminated |
| Z-0345-2014 Class II | ADVIA 1800 System Software V2.01. Performs assays for general and specialty chemistries…Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging… | 09/03/2013Terminated |
| Z-0346-2014 Class II | ADVIA 2400 System Software V4.01. Performs assays for general and specialty chemistries…Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging… | 09/03/2013Terminated |