FDA Device recall Z-0155-2020
Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer intended for clinical use
- FDA Device
- Class II
- terminated
- Published 2019-10-23
On 2019-10-23 the FDA classified a Class II recall of Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer intended for clinical use by Vital Scientific N V, citing the action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0155-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-01-10 |
| Published | 2019-10-23 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Vital Scientific N V |
| Distribution | US |
Product
Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer intended for clinical use
Reason
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
Identifiers
| code_info | serial numbers: 10-4582 till 10-4584; 10-4586 till 10-4594; 11-2309; 11-2320 t through 11-2328; 11-2330 through-233…serial numbers: 10-4582 till 10-4584; 10-4586 till 10-4594; 11-2309; 11-2320 t through 11-2328; 11-2330 through-2334; 11-2336 through 11-2375; 11-2383; 11-2384; 11-2388; 11-2395; 12-2314; 12-2315; 12-2324 12-2325. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0155-2020%22
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