FDA Device recall Z-0547-2020
V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180
- FDA Device
- Class II
- ongoing
- Published 2019-12-04
On 2019-12-04 the FDA classified a Class II recall of V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180 by Vital Scientific N V, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0547-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-11-15 |
| Published | 2019-12-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Vital Scientific N V |
| Distribution | NY |
Product
V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180
Reason
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.
Identifiers
| code_info | (OUS) V-Twin¿ 6002-800 serial numbers from 3-3021 till 18-3345; (US) V-Twin¿6002-850 serial numbers from 3-3006 till 9-4037 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0547-2020%22
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