V-Twin — Class II medical device recall Z-0038-2020
Terminated recall by Vital Scientific N.V., reported 2019-10-16, distributed nationwide. The action is being initiated because the cooling indicator board was improperly installed. This was first not
| Recall number | Z-0038-2020 |
|---|---|
| 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 | 2018-09-07 |
| Classified | 2019-10-04 |
| Reported by FDA | 2019-10-16 |
| Terminated | 2022-06-29 |
| Distributed | Nationwide (US) |
| Quantity | 192 devices |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 03661540600180 |
| Serial numbers | 14-3301-14-3344, 15-3301-15-3326, 16-3301, 16-3353, 17-3301, 17-3346, 18-3301-18-3323 |
| Model numbers | 6002-800 |
Product
V-Twin, Catalog # 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
The action is being initiated because the cooling indicator board was improperly installed. This was first noticed by a service employee during assembly. If for some reason the cooling of the reagent rotor fails, the reagent cooling indicator light will not illuminate and the acoustic beeper will not go off. As a consequence the operator will not be warned and the reagent storage conditions may fall out of specification.
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-0038-2020. 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.