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Agilent Technologies, Inc. recalls MassHunter Quantitative Analysis Software, Version B.07.01, used with Triple Quadrupole Mass Spectrometers, models K6460
Recalled September 4, 2019 · FDA recall Z-2359-2019 · Agilent Technologies
Hazard
When utilizing specific software versions of an LC/MS device, and Batch at a Glance in Compound Table view, a defect occurs when a new sample(s) is inserted. This defect creates a mismatch between the sample name and the column header whereby the sample header will be offset by one sample. The recalling firm requests that you discontinue using this workflow to generate reports because the Quant batch table will not display fully analyzed results or save any changes made. · FDA Class II
Units
235
Sold at
US Nationwide. distribution.
Description
When utilizing specific software versions of an LC/MS device, and Batch at a Glance in Compound Table view, a defect occurs when a new sample(s) is inserted. This defect creates a mismatch between the sample name and the column header whereby the sample header will be offset by one sample. The recalling firm requests that you discontinue using this workflow to generate reports because the Quant batch table will not display fully analyzed results or save any changes made.
Product
MassHunter Quantitative Analysis Software, Version B.07.01, used with Triple Quadrupole Mass Spectrometers, models K6460 and K6420 Product Usage: A mass spectrometer for clinical use is a device intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass.
Manufacturer(s)
Agilent Technologies, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →