FDA Device recall Z-2558-2019
V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer, micro…
- FDA Device
- Class II
- ongoing
- Published 2019-10-02
On 2019-10-02 the FDA classified a Class II recall of V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer, micro… by Vital Scientific N V, citing instrument stopped working due to a software lockup, and no patient results are produced.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2558-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2016-01-18 |
| Published | 2019-10-02 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Vital Scientific N V |
| Distribution | NY |
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
Instrument stopped working due to a software lockup, and no patient results are produced.
Identifiers
| code_info | Serial #s: 13-3341 and 13-3344 |
|---|
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-2558-2019%22
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