Z-2528-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 24, 2016
- Initiation Date
- June 16, 2016
- Termination Date
- March 2, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 121 units
Product Description
AB SCIEX Triple Quad 4500MD LC/MS/MS System. Mass Spectrometer for In-Vitro Diagnostic Use. Instrument Part Number (REF): 5031257 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.
Reason for Recall
MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative results when using the Sum Multiple Ions feature.
Distribution Pattern
Worldwide Distribution - US (Nationwide) Internationally to Canada, Austria, China, Netherlands, Norway, India, Korea, Germany, France, Switzerland, Ireland, Italy, Singapore, Russia, UK, Malaysia,
Code Information
Software Version: MultiQuant MD 3.0, MultiQuant MD 3.0.1 and MultiQuant MD 3.0.2 software