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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves incorrect quantitative results in diagnostic testing, which poses a risk of harm to patients through potential misdiagnosis, but no specific injuries or illnesses are reported in the source text.
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 Triple Quad 4500MD LC/MS/MS System. The recall affects 121 units of the mass spectrometer intended for in-vitro diagnostic use. The software is distributed worldwide, including in the United States, Canada, and various countries in Europe, Asia, and the Middle East.
The recall was initiated because, under certain conditions, the software may present users with incorrect quantitative results when the Sum Multiple Ions feature is utilized. This system is designed to identify inorganic or organic compounds, such as lead, mercury, and drugs, in human specimens.
Users of the affected software should contact Ab Sciex for further instructions on how to address the issue. The recall is classified as Class II by the FDA, indicating that use of the product could, in some cases, cause temporary or medically reversible adverse health consequences.
The recalled product
- 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
- Manufacturer
- Ab Sciex
- Affected units
- 121
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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