Recall Z-2529-2016— Ab Sciex
Class II · Terminated
Class II FDA medical device recall by Ab Sciex, initiated 2016-06-16, terminated 2017-03-02. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative results when using the Sum Multiple Ions feature..
- Recalling firm
- Ab Sciex
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-06-16
- Terminated
- 2017-03-02
- Firm location
- Framingham, MA, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.