V-Twin — Class II medical device recall Z-0547-2020
Ongoing recall by Vital Scientific N.V., reported 2019-12-04, distributed in NY. During in-house testing it was determined that their is a possibility that during a sample run, the instrument
| Recall number | Z-0547-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vital Scientific N.V., Dieren, Netherlands |
| Recall initiated | 2018-11-15 |
| Classified | 2019-11-22 |
| Reported by FDA | 2019-12-04 |
| Distributed | NY |
| Quantity | 732 instruments |
| UPC / GTIN / UDI-DI | 03661540600180 |
| Model numbers | 18-3304, 6002-800, 6002-850 |
Product
V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180
Reason for recall
During in-house testing it was determined that their is a possibility that during a sample run, the instrument may aspirate a sample from the wrong sample container resulting in a sample result and patient ID mismatch. If not detected, this may lead to an incorrect patient report.
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-0547-2020. 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.