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.
Enforcement
- Recall Number
- Z-0038-2020
- Event ID
- 83648
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Vital Scientific N.V.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- October 16, 2019
- Initiation Date
- September 7, 2018
- Classification Date
- October 4, 2019
- Termination Date
- June 29, 2022
- Address
- 24, Kanaalweg, Postbus 100, Dieren, N/A, N/A, Netherlands
Description
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.
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.
The following serial numbers: 14-3301-14-3344; 15-3301-15-3326; 16-3301 -16-3353; 17-3301 -17-3346; 18-3301-18-3323
US Nationwide distribution including the state of New York.
192 devices