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U.S. Department of Health and Human Services

Class 2 Device Recall K6460 Triple Quadrupole MS

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  Class 2 Device Recall K6460 Triple Quadrupole MS see related information
Date Initiated by Firm August 15, 2018
Create Date August 23, 2019
Recall Status1 Terminated 3 on September 28, 2021
Recall Number Z-2359-2019
Recall Event ID 82794
Product Classification Mass spectrometer, clinical use - Product Code DOP
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.
Code Information Software versions B.07 or below
Recalling Firm/
Manufacturer		 Agilent Technologies, Inc.
5301 Stevens Creek Blvd
Santa Clara CA 95051-7201
For Additional Information Contact Ryan Rademacher
408-797-6269
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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