FDAJune 16, 2016device
AB Sciex API 3200MD" LC/MS/MS System. In-Vitro Diagnostic Instrument Part Number (REF): 5024501 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 investigati...
Official recall recorded by the U.S. Food & Drug Administration.
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
FDA enforcement status: Terminated
Brands named
ab sciex
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDA4500MD Triple Quad Mass Spectrometer, Part Number 50325222023-08-30
- FDAAPI3200MD Mass Spectrometer, Part Number 44662302023-08-30
- FDACitrine Triple Quad Mass Spectrometer, Part Number 50636842023-08-30
- FDACitrine QTRAP Mass Spectrometer, Part Number 50636852023-08-30
- FDACliquid MD version 3.4 software used in conjunction with Analyst MD software on SCIEX Citrine & 4500MD series liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems. Model No. 50882882021-10-04
- FDAAB 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 th...2016-06-16
- FDAAB 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 ioniz...2016-06-16
- FDAAB SCIEX 3200MD QTRAP¿ LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic Use. Instrument Part Number (REF): 5024500 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 th...2016-06-16
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