Z-2359-2019Class II

MassHunter Quantitative Analysis Software, Version B.07.01, used with Triple Quadrupole Mass Spectrometers...

Name: Z-2359-2019 MassHunter Quantitative Analysis Software, Version B.07.01, used with Triple Quadrupole Mass Spectrometers...
Creator: Agilent Technologies, Inc.
Published: 2018-08-15
License: https://open.fda.gov/license/

Agilent Technologies, Inc. / initiated 2018-08-15 / Terminated / root cause: software

FDA source

Agilent Technologies, Inc. began a recall of MassHunter Quantitative Analysis Software, Version B.07.01, used with Triple Quadrupole Mass Spectrometers, models K6460 and K6420 Product Usage: A mass... on 2018-08-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2359-2019
Classification: Class II
Status: Terminated
Initiated: 2018-08-15
Posted: 2019-08-23
Terminated: 2021-09-28
Recalling firm: Agilent Technologies, Inc.
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.
Product code: DOP Mass Spectrometer, Clinical Use
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.
Root cause tag: software
FDA root cause: Software design
Action: On 08/13/18, Urgent Medical Device Recall notices were sent to customers informing them that the defect has been corrected with software version B.08.01. The recalling firm will contact customers to schedule the new software installation. Software version B.08.01 is being released in conjunction with software version B.08.03. This software suite includes improvements to other non-patient safety related defects such as the following fixes in Acquisition B.08.03. -Improvements to DMRM method setup which will prevent exceeding transition limits ("Failed to WriteScan" errors). Improvements to MassHunter Optimizer preventing intermittently missed entries that give "Phase 3Optimization" error.A full list of defects is contained in the Software Release Bulletin supplied with your software. Customers with additional questions were encouraged to call 1-866-488-4080. Customers were asked to complete and return an acknowledgement form.
Quantity in commerce: 235
Distribution: US Nationwide. distribution.
Product codes and lots: Software versions B.07 or below

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2359-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2359-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-04	2019-08-23

Product code DOP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)