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.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves incorrect quantitative results in a diagnostic instrument without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Ab Sciex is recalling the MultiQuant MD software (versions 3.0, 3.0.1, and 3.0.2) used with the AB SCIEX 3200MD QTRAP LC/MS/MS System. The recall involves 2 units of the instrument, which are mass spectrometers intended for in-vitro diagnostic use to identify compounds in human specimens.
The recall is due to a software defect where, under certain conditions, users may be presented with incorrect quantitative results when utilizing the Sum Multiple Ions feature. This issue could affect the accuracy of diagnostic data generated by the instrument.
The affected software was distributed worldwide, including in the United States, Canada, and various international locations. Users of the affected software should contact Ab Sciex for further instructions on how to resolve the issue.
The recalled product
- 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
- Manufacturer
- Ab Sciex
- Hazard
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Software Version: MultiQuant MD 3.0
- MultiQuant MD 3.0.1 and MultiQuant MD 3.0.2 software
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Ab Sciex under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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