Recall Z-2558-2019
Vital Scientific N.V. · initiated January 18, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Serial #s: 13-3341 and 13-3344
Reason for recall
Instrument stopped working due to a software lockup, and no patient results are produced.
FDA-determined cause: Software Manufacturing/Software Deployment
Action taken
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.
Details
- Recall number
- Z-2558-2019
- Initiated
- January 18, 2016
- Product code
- JJF – Analyzer, Chemistry, Micro, For Clinical Use
- Quantity
- 2
- Distribution
- US in the state of New York.
- Recalling firm
- Vital Scientific N.V., Dieren