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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 July 15, 2014
Date Posted September 08, 2014
Recall Status1 Terminated 3 on October 01, 2014
Recall Number Z-2609-2014
Recall Event ID 68821
Product Classification Mass spectrometer, clinical use - Product Code DOP
Product AB SCIEX API 3200MD" LC/MS/MS System with software:
MultiQuantMD 3.0In vitro diagnostic to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens
Part Number 5024543.
Code Information Serial Numbers: BV20031308, BV20081311, BV20051310, BV20071311, BV20101401, BV20131401
Recalling Firm/
Manufacturer		 Ab Sciex
500 Old Connecticut Path
Framingham MA 01701-4574
Manufacturer Reason
for Recall		 Software- AB SCIEX API 3200MD LC/MS/MS SYSTEM with MultiQuantMD 3.0 software may provide incorrect data for patient diagnosis
FDA Determined
Cause 2		 Software design
Action AB SIEX issued letter on 7/15/14, notifying customers to implement this field correction, a temporary fix to be implemented immediately. Additionally, a software update is in development and is expected to be available in approximately 8 weeks. Upon availability, AB SCIEX will send a DVD with instructions on how to install the new software update. At that time, outlined temporary actions will no longer be necessary. If you have any questions regarding this recall, potential hazards or actions to be taken please feel free to contact AB SCI EX at +1 289 982 2531. Please confirm receipt of this letter by signing and faxing back the attached Acknowledgement Form.
Quantity in Commerce 6 units
Distribution FL, NC, OK, PA, TX
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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