FDA Device recall Z-0157-2020
Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product Usage: :clinical chemis…
- FDA Device
- Class II
- terminated
- Published 2019-10-23
On 2019-10-23 the FDA classified a Class II recall of Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product Usage: :clinical chemis… 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-0157-2020 |
| 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
Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
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: 11-7425; 11-7516; 11-7535; 11-7563; 11-7564. |
|---|
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-0157-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.