V-Twin — Class II medical device recall Z-2558-2019
Ongoing recall by Vital Scientific N.V., reported 2019-10-02, distributed in NY. Instrument stopped working due to a software lockup, and no patient results are produced.
| Recall number | Z-2558-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vital Scientific N.V., Dieren, Netherlands |
| Recall initiated | 2016-01-18 |
| Classified | 2019-09-23 |
| Reported by FDA | 2019-10-02 |
| Distributed | NY |
| Quantity | 2 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 03661540600180 |
| Serial numbers | 13-3341, 13-3344 |
| Model numbers | 6002-800 |
Product
V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.
Reason for recall
Instrument stopped working due to a software lockup, 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-2558-2019. 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.