FDAAugust 15, 2018device

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 specimen...

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

agilent technologiesagilent

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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