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U.S. Department of Health and Human Services

Class 2 Device Recall Citrine QTRAP Mass Spectrometer

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  Class 2 Device Recall Citrine QTRAP Mass Spectrometer see related information
Date Initiated by Firm August 30, 2023
Date Posted October 05, 2023
Recall Status1 Open3, Classified
Recall Number Z-0039-2024
Recall Event ID 92810
Product Classification Mass spectrometer, clinical use - Product Code DOP
Product Citrine QTRAP Mass Spectrometer, Part Number 5063685
Code Information UDI-DI: 00842365100540; Serial Numbers: DD250051901, DD250172009, DD250182009, DD230001804, DD250111910, DD250132004, DD250091909, DD250101910, DD250192010, CN10011707PT
Recalling Firm/
Manufacturer		 AB Sciex, LLC
500 Old Connecticut Path
Framingham MA 01701-4574
For Additional Information Contact
877-740-2129
Manufacturer Reason
for Recall		 In rare occasions, the combination of a leak of a highly flammable solvent at the ion source probe, and an electrical discharge may result in a flame on top of the probe and possible ejection of the electrode assembly from the probe. There is a risk to the patient/user, customer property, or environment because there is a potential for a health risk and property damage should the flame be left unattended. The failure causes a delay in patient results.
FDA Determined
Cause 2		 Component design/selection
Action An URGENT: RUO and MEDICAL DEVICE FIELD ACTION notification letter dated 7/20/23 was sent to customers. Actions to be taken by the Customer/User: SCIEX will provide a replacement nut for eligible sources and systems. Instructions will be provided to guide you through the replacement of the nut. The replacement parts with installation instructions are estimated to begin shipping in October 2023. SCIEX is currently notifying affected customers of the upcoming countermeasure. Upon availability, SCIEX will send you the replacement nut with instructions on how to install it on the ion source probe. We sincerely apologize for any inconvenience that this may cause you. SCIEX aims to provide you with products of the highest quality. If you have any questions regarding this notice, please contact https://sciex.com/aboutus/ contact-us or https://sciex.com/support/request-support.
Quantity in Commerce 10
Distribution US Nationwide.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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