Summary
The FDA issued a Class II for Citrine QTRAP Mass Spectrometer, Part Number 5063685 by AB Sciex, LLC. Reason: 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 .
Details
Source
Device Recall
External ID
Z-0039-2024
Action Date
2023-10-11
Status
Ongoing
Category
device
Product Description
Citrine QTRAP Mass Spectrometer, Part Number 5063685
Lot/Code Info: UDI-DI: 00842365100540; Serial Numbers: DD250051901, DD250172009, DD250182009, DD230001804, DD250111910, DD250132004, DD250091909, DD250101910, DD250192010, CN10011707PT
Quantity Affected: 10
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.
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-30
Company
Framingham, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 142 device recalls issued in the same week, part of 403 device-related FDA actions this month.
AB Sciex, LLC has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (AB Sciex, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does AB Sciex, LLC have FDA actions?
AB Sciex, LLC has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0039-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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