Device product
AB SCIEX QTRAP¿ 4500MD LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic Use. Instrument Part Number (REF): 5031231 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass. It is intended for in vitro diagnostic purposes. For in vitro diagnostic use.
Z-2529-2016
Product summary
- Firm
- Ab Sciex
- Event
- Event 74520
- Status
- Terminated
- Classification
- Class II
- Quantity
- 28 units
- Official record key
device-enforcement:Z-2529-2016
Official wording
Reason: MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative results when using the Sum Multiple Ions feature.
Code information: Software Version: MultiQuant MD 3.0, MultiQuant MD 3.0.1 and MultiQuant MD 3.0.2 software
Distribution pattern: Worldwide Distribution - US (Nationwide) Internationally to Canada, Austria, China, Netherlands, Norway, India, Korea, Germany, France, Switzerland, Ireland, Italy, Singapore, Russia, UK, Malaysia,
Derived failure modes
-
Device software or design
software where under certain conditions a user can