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 Initiated
- January 18, 2016
- Recall Number
- Z-2558-2019
- Quantity
- 2
Reason for Recall
Instrument stopped working due to a software lockup, and no patient results are produced.
Distribution
US in the state of New York.
Lot / Code Info
Serial #s: 13-3341 and 13-3344
Root 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.
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