Recall Z-0154-2020 ยท JJF Analyzer, Chemistry, Micro, For Clinical Use
Vital Scientific N.V.
Viva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: automated chemistry analyzer intended for clinical use
| Date | Jan 10, 2012 |
| Status | Terminated |
| Reason | The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced. |
| Root cause | Component design/selection |
| Action | The firm reached out to consignees via phone to inform them of the affected product. |
| Quantity | 4 units |
| Distribution | US Nationwide in the states of NY, and UT |
| 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 |