Device 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.
Z-2558-2019
Product summary
- Event
- Event 83607
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2
- Official record key
device-enforcement:Z-2558-2019
Official wording
Reason: Instrument stopped working due to a software lockup, and no patient results are produced.
Code information: Serial #s: 13-3341 and 13-3344
Distribution pattern: US in the state of New York.
Derived failure modes
-
Unknown
Instrument stopped working due to a software lockup, and no patient results are produced.