04

Sep

2019

Recall – Quantitative analysis software error leads to results mismatch

recall, softwareerror

0

Company: Agilent Technologies, Inc.
Date of Enforcement Report: 9/4/2019
Class II

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.

Recall Number: Z-2359-2019

REASON

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.

RECALLING FIRM/MANUFACTURER

Agilent Technologies, Inc. on 8/15/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

235

DISTRIBUTION

US Nationwide

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