Citrine Triple Quad Mass Spectrometer, Part Number 5063684
This recall is currently active, issued October 5, 2023. It was issued by Ab Sciex, Llc.
- Company
- Ab Sciex, Llc
- Recall Initiated
- August 30, 2023
- Posted
- October 5, 2023
- Recall Number
- Z-0040-2024
- Quantity
- 14
- Firm Location
- Framingham, MA
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
UDI-DI: 00842365100533; Serial Numbers: DE220001803PL, DE230011804, DE230031806, DE230041807, DE230051808, DE230071901, DE230081903, DE230091903, DE230162003, DE230272105, DE230292105, DE240002106, DE240022111, DE240042203
Root Cause
Component design/selection
Action Taken
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.