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U.S. Department of Health and Human Services

Class 2 Device Recall AB SCIEX

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  Class 2 Device Recall AB SCIEX see related information
Date Initiated by Firm June 16, 2016
Date Posted August 12, 2016
Recall Status1 Terminated 3 on March 02, 2017
Recall Number Z-2528-2016
Recall Event ID 74520
Product Classification Mass spectrometer, clinical use - Product Code DOP
Product AB SCIEX Triple Quad 4500MD LC/MS/MS System. Mass Spectrometer for In-Vitro Diagnostic Use.
Instrument Part Number (REF): 5031257
3200MD series and 4500MD series are mass spectrometers 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. It is intended for in vitro diagnostic purposes. For in vitro diagnostic use.
Code Information Software Version: MultiQuant MD 3.0, MultiQuant MD 3.0.1 and MultiQuant MD 3.0.2 software
Recalling Firm/
Manufacturer		 Ab Sciex
500 Old Connecticut Path
Framingham MA 01701-4574
Manufacturer Reason
for Recall		 MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative results when using the Sum Multiple Ions feature.
FDA Determined
Cause 2		 Software design
Action AB SCIEX issued recall notification by letter dated June 16, 2016, to all affected customers. The letter identified the problem, provided temporary measures until a permanent software is available. A response form was to be completed and returned. questions regarding this notice contact SCI EX at +1 289 982 2712.
Quantity in Commerce 121 units
Distribution Worldwide Distribution - US (Nationwide) Internationally to Canada, Austria, China, Netherlands, Norway, India, Korea, Germany, France, Switzerland, Ireland, Italy, Singapore, Russia, UK, Malaysia,
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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