MassHunter Quantitative Analysis Software — Class II medical device recall Z-2359-2019
Terminated recall by Agilent Technologies, Inc., reported 2019-09-04, distributed nationwide. When utilizing specific software versions of an LC/MS device, and Batch at a Glance in Compound Table view, a
| Recall number | Z-2359-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Agilent Technologies, Inc., Santa Clara, CA, United States |
| Recall initiated | 2018-08-15 |
| Classified | 2019-08-23 |
| Reported by FDA | 2019-09-04 |
| Terminated | 2021-09-28 |
| Distributed | Nationwide (US) |
| Quantity | 235 |
| Reason classes | software |
| Model numbers | K6420, K6460 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2359-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.