FDAFDA · Food and drugs·Recall number Z-2529-2016
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.
Published August 24, 2016 · Recall initiated: June 16, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative results when using the Sum Multiple Ions feature.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ab Sciex
- Distributor
- Worldwide Distribution - US (Nationwide) Internationally to Canada, Austria, China, Netherlands, Norway, India, Korea, Germany, France, Switzerland, Ireland, Italy, Singapore, Russia, UK, Malaysia,
- Lot
- Software Version: MultiQuant MD 3.0, MultiQuant MD 3.0.1 and MultiQuant MD 3.0.2 software
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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