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.
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 diagnostic results, which is a risk-of-harm product issue where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Ab Sciex is recalling 124 units of the API 3200MD LC/MS/MS System, specifically the MultiQuant MD software versions 3.0, 3.0.1, and 3.0.2. The recall is due to a defect where, under certain conditions, users may be presented with incorrect quantitative results when utilizing the Sum Multiple Ions feature.
The affected instruments are mass spectrometers intended for in vitro diagnostic purposes, used to identify inorganic or organic compounds in human specimens. The distribution of these units was worldwide, including the United States and various international locations such as Canada, China, and the United Kingdom.
Healthcare facilities and laboratories using these systems should contact Ab Sciex for instructions on how to address the software issue. The recall is classified as Class II by the FDA, indicating a situation where use of the product could cause temporary or medically reversible health consequences.
The recalled product
- 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
- Manufacturer
- Ab Sciex
- Hazard
- Affected units
- 124
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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