Recall Z-2558-2019 ยท JJF Analyzer, Chemistry, Micro, For Clinical Use
Vital Scientific N.V.
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.
| Date | Jan 18, 2016 |
| Status | Open, Classified |
| Reason | Instrument stopped working due to a software lockup, and no patient results are produced. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | 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. |
| Quantity | 2 |
| Distribution | US in the state of New York. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K973628 | VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA Vital Scientific N.V., Mar 13, 1998 |