FDAOctober 4, 2021device
Cliquid 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. 5088288
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The values of the Internal Standard (IS) concentrations are incorrectly derived when the user builds a customized test, then set the IS column to hidden and left the column empty. This may lead to the user making incorrect conclusions using incorrect results.
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.
- FDAAPI3200MD Mass Spectrometer, Part Number 44662302023-08-30
- FDACitrine Triple Quad Mass Spectrometer, Part Number 50636842023-08-30
- FDA4500MD Triple Quad Mass Spectrometer, Part Number 50325222023-08-30
- FDACitrine QTRAP Mass Spectrometer, Part Number 50636852023-08-30
- 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 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
- 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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