Selectra ProM Analyzer — Class II medical device recall Z-0157-2020
Terminated recall by Vital Scientific N.V., reported 2019-10-23, distributed nationwide. The action was initiated due power supply failure. During a power supply failure the instruments malfunctions
| Recall number | Z-0157-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vital Scientific N.V., Dieren, N/A, Netherlands |
| Recall initiated | 2012-01-10 |
| Classified | 2019-10-16 |
| Reported by FDA | 2019-10-23 |
| Terminated | 2024-04-19 |
| Distributed | Nationwide (US) |
| Quantity | 5 instruments |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 03661540600395, 03661540600401 |
| Serial numbers | 11-7425, 11-7516, 11-7535, 11-7563, 11-7564 |
| Model numbers | 6003-435, 6003-436 |
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 for recall
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0157-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.