Z-0038-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 16, 2019
- Initiation Date
- September 7, 2018
- Termination Date
- June 29, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 192 devices
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.
Distribution Pattern
US Nationwide distribution including the state of New York.
Code Information
The following serial numbers: 14-3301-14-3344; 15-3301-15-3326; 16-3301 -16-3353; 17-3301 -17-3346; 18-3301-18-3323