FDA Medical Device Recalls (openFDA)
Agilent Technologies, Inc.: 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
- 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.
- Status
- Terminated
- Initiated
- 2018-08-15
- Posted
- not on file
- Terminated
- 2021-09-28
- 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.
- 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
- 235
- Distribution
- US Nationwide. distribution.
- Lot, serial or model codes
- Software versions B.07 or below
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DOP
- Firm FEI
- 2916205
- Firm city
- Santa Clara
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28