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.

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.