4500MD Triple Quad Mass Spectrometer, Part Number 5032522
FDA Recall Z-0038-2024 · Posted 2023-10-05
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Recalling FirmAB Sciex, LLC
Recall StatusOpen, Classified
Product CodeDOP
Date Initiated2023-08-30
Product Quantity38
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.
Firm 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.
Root Cause
Component design/selection
Distribution Pattern
US Nationwide.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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