# FDA recall Z-2359-2019

> **Agilent Technologies, Inc.** · Class II · device recall initiated 2018-08-15.

## 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.

## Reason for recall

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.

## Distribution

US Nationwide.  distribution.

## Key facts

- **Recall number:** Z-2359-2019
- **Recalling firm:** Agilent Technologies, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-15
- **Report date:** 2019-09-04
- **Termination date:** 2021-09-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Santa Clara, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2359-2019

## Citation

> AI Analytics. FDA recall Z-2359-2019. Retrieved 2026-06-13 from https://api.ai-analytics.org/recall/Z-2359-2019. Source: US FDA. Licensed CC0.

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