Z-2558-2019 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 2, 2019
- Initiation Date
- January 18, 2016
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
Product Description
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 for Recall
Instrument stopped working due to a software lockup, and no patient results are produced.
Distribution Pattern
US in the state of New York.
Code Information
Serial #s: 13-3341 and 13-3344