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.
This recall has been terminated (originally issued August 15, 2018).
- Company
- Agilent Technologies, Inc.
- Recall Initiated
- August 15, 2018
- Terminated
- September 28, 2021
- Recall Number
- Z-2359-2019
- Quantity
- 235
- Firm Location
- Santa Clara, CA
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Software versions B.07 or below
Root Cause
Software design
Action Taken
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.