FDAFebruary 24, 2016device
Analyst¿ MD Version 1.6.1 and 1.6.2 Software used with the following instruments: API 3200MD" LC/MS/MS System, Instrument Part Number: 5024501; 3200MD QTRAP¿ LC/MS/MS System, Instrument Part Number: 5024500; Triple Quad" 4500MD LC/MS/MS System, Instrument Part Number: 5031257; QTRAP¿ 4500MD LC/MS...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Wrong quantitative results may be displayed in a report from the device, which may potentially lead to an incorrect patient diagnosis.
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 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...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
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