AB Sciex Mass Spectrometers Recalled for Incorrect Quantitative Results
AB Sciex is recalling two models of mass spectrometers used for in vitro diagnostics because they may report incorrect quantitative results under certain conditions.
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, and the hazard involves a risk of harm (incorrect diagnostic results) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
AB Sciex is recalling the Triple Quad 4500MD LC/MS/MS System (Part No. 5031257) and the QTRAP 4500MD LC/MS/MS System (Part No. 5031231). These are mass spectrometers intended for in vitro diagnostic use only. The recall involves 2 units that were distributed to the state of North Carolina.
The recall is being issued because, under certain conditions, the mass spectrometers may report incorrect quantitative results. The source text does not specify the exact conditions that trigger this error, nor does it report any specific patient injuries or illnesses resulting from the use of these devices.
Users of these devices should contact AB Sciex for instructions on how to resolve the issue. The specific serial numbers affected are listed in the agency's recall record Z-1671-2016.
The recalled product
- Product
- AB Sciex Triple Quad 4500MD LC/MS/MS System, Part No. 5031257; and QTRAP 4500MD LC/MS/MS System, Part No. 5031231. Mass spectrometers for in vitro diagnostic use only.
- Manufacturer
- Ab Sciex
- Hazard
- Affected units
- 2
Distribution
Distributed in 1 state:
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