The Recall Desk

FDA (Devices) recall action 74520

Ab Sciex recalled 4 products on 2016-08-24

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2016-08-24
Critical
0
Units
275

Why these products were recalled

MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative results when using the Sum Multiple Ions feature.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–4 of 4

  • HighFDA (Devices)··2016-08-24

    Ab Sciex API 3200MD Software Recall for Incorrect Quantitative Results

    Ab Sciex is recalling MultiQuant MD software for API 3200MD systems due to potential incorrect quantitative results when using the Sum Multiple Ions feature.

    Product
    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 compoun
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    0 states
  • HighFDA (Devices)··2016-08-24

    Ab Sciex QTRAP 4500MD Mass Spectrometer Software Recall for Incorrect Results

    Ab Sciex is recalling 28 QTRAP 4500MD mass spectrometers because MultiQuant MD software may display incorrect quantitative results when using the Sum Multiple Ions feature.

    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 spe
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    0 states
  • ModerateFDA (Devices)··2016-08-24

    Ab Sciex 3200MD Mass Spectrometer Software Recall for Incorrect Results

    Ab Sciex is recalling MultiQuant MD software for 3200MD mass spectrometers because it may display incorrect quantitative results when using the Sum Multiple Ions feature.

    Product
    AB 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 spe
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    Distribution
    0 states
  • HighFDA (Devices)··2016-08-24

    Ab Sciex Mass Spectrometer Software Recall for Incorrect Quantitative Results

    Ab Sciex is recalling MultiQuant MD software for Triple Quad 4500MD systems because it may display incorrect quantitative results when using the Sum Multiple Ions feature.

    Product
    AB 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 hum
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    0 states