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U.S. Department of Health and Human Services

Class 2 Device Recall PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD

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  Class 2 Device Recall PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD see related information
Date Initiated by Firm September 24, 2018
Create Date November 28, 2018
Recall Status1 Terminated 3 on September 17, 2019
Recall Number Z-0513-2019
Recall Event ID 81266
Product Classification Mass spectrometer, clinical use - Product Code DOP
Product PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD v1.0 with Hot Fix 2 Software intended to identify compounds in human samples by ionizing the compound and separating the resulting ions. Part Number: BC004872
Code Information 210MDBC709100008 210MD8C709140010 210MD8C709150009 210MDBC709160011 210MDBC709180012 210MDBC709200013 210MD8C710020014 210MDBC710050016 210MD8C710110018 210MDBC710170020 210MD8C710180022 210MD8C712220428 210MDBC801240030 210MDBC801250031 210MDBC802140032 210MD8C802150033 210MD8C802260035 210MDBC803190037
Recalling Firm/
Manufacturer		 PerkinElmer Health Sciences Canada, Inc.
32 Nixon Rd Unit 1
Bolton Canada
Manufacturer Reason
for Recall		 Under certain conditions when using PerkinElmer QSight 210 MD mass spectrometer with Simplicity 3Q MD and Hotfix 2 software, it is possible for the original data from the last acquired sample to be over-written when the automatic flush is enabled.
FDA Determined
Cause 2		 Software design
Action Perkin Elmer issued notification on 9/24/18 customers are requested to follow instructions contained within the Urgent Medical Device Correction letter and disseminate the information to appropriate functions within their organization. Inform relevant personnel and execute one of the following two options: Qption 1 (Users who do not require Autamatic Flushinq): Deactivate the automatic flushing option in your software: 1) Navigate to the Batch Acquisition Queue tab 2) Click the Queue Options button 3) Under the "System Flush and Standby" section, DESELECT the "Enable automatic flushing" option. Option 2 (Users who require Automatic Flushinqt: Add a non data (blank or "dummy") sample to the acquisition queue to be run as your final sample (before going to Flush/standby). This will ensure that a true sample or control data are not overwritten. Contact PerkinElmer Heatth Scbnces C,arda, Bolton facility Quality Manager- SandiOrdog for further information (647. 505. 8682). The issue identified above will be addressed through a software update. PerkinElmer will contact you when the fix is available and upgrade your software.
Quantity in Commerce 18 units
Distribution FL, MN, PA India, Italy, Korea, Spain
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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