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U.S. Department of Health and Human Services

Class 2 Device Recall AB SciexTriple Quad 4500MD LC/MS/MS System.

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  Class 2 Device Recall AB SciexTriple Quad 4500MD LC/MS/MS System. see related information
Date Initiated by Firm March 25, 2016
Create Date May 15, 2016
Recall Status1 Terminated 3 on May 23, 2016
Recall Number Z-1671-2016
Recall Event ID 73786
Product Classification Mass spectrometer, clinical use - Product Code DOP
Product AB Sciex Triple Quad 4500MD LC/MS/MS System, Part No. 5031257; and QTRAP 4500MD LC/MS/MS System, Part No. 5031231.

Mass spectrometers for in vitro diagnostic use only.
Code Information Serial Numbers:  Triple Quad 4500MD LC/MS/MS System BX21081601 BX21101601 BX21091601 BX21111601 BX21121602 BX21131602 BX21141602 BX21151602  QTRAP 4500MD LC/MS/MS System BW20251601 BW20241601 BW20261602
Recalling Firm/
Manufacturer		 Ab Sciex
500 Old Connecticut Path
Framingham MA 01701-4574
Manufacturer Reason
for Recall		 Under certain conditions, mass spectrometers may report incorrect quantitative results.
FDA Determined
Cause 2		 Under Investigation by firm
Action AB SCIEX issued Urgent: Medical Device Correction letter, dated 3/25/16, advising user of the problem and advising not to use the system until corrected. The letter also discussed the risk to health, as well as how to recognize if the issue has occurred. Sciex Field Service Employee (FSE) will be sent to customer site to perform the field corrective action on the affected system. Questions regarding the letter should be directed to SCIEX at 1-289-982-2531.
Quantity in Commerce 2 units
Distribution Distributed to the state of NC.
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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