Recall Z-0038-2020— Vital Scientific N.V.
Class II · Terminated
Class II FDA medical device recall by Vital Scientific N.V., initiated 2018-09-07, terminated 2022-06-29. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- Vital Scientific N.V.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-09-07
- Terminated
- 2022-06-29
- Firm location
- Dieren, N/A, Netherlands
Product 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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.