V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.
Recall
- Recall Number
- Z-2558-2019
- Event Number
- 83607
- Firm
- Vital Scientific N.V. 24, Kanaalweg Postbus 100 Dieren Netherlands
- FEI Number
- 2708
- Product Code
- JJF
- Status
- Open, Classified
- Root Cause
- Software Manufacturing/Software Deployment
- Initiated
- January 18, 2016
Description
V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.
Instrument stopped working due to a software lockup, and no patient results are produced.
In very close cooperation with the consignees, the affected end users running on EPROM version V1.2.3 were contacted. Initially, a temporary work around (reset of the software) was communicated with the consignees. The consignees devices were installed to document all errors during runtime .In addition, a new software was developed and tested. The new software resulted in version 1.2.5 of EPROM, which was released June 23, 2016. Consignees of the V-Twin all received a field update kit with the new software.
US in the state of New York.
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