Recall Z-0040-2024
AB Sciex, LLC · initiated August 30, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Citrine Triple Quad Mass Spectrometer, Part Number 5063684
Codes / lots: UDI-DI: 00842365100533; Serial Numbers: DE220001803PL, DE230011804, DE230031806, DE230041807, DE230051808, DE230071901, DE230081903, DE230091903, DE230162003, DE230272105, DE230292105, DE240002106, DE240022111, DE240042203
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: 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.
Details
- Recall number
- Z-0040-2024
- Initiated
- August 30, 2023
- Posted by FDA
- October 5, 2023
- Product code
- DOP – Mass Spectrometer, Clinical Use
- Quantity
- 14
- Distribution
- US Nationwide.
- Recalling firm
- AB Sciex, LLC, Framingham, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0037-2024 Class II | API3200MD Mass Spectrometer, Part Number 4466230In rare occasions, the combination of a leak of a highly flammable solvent at the ion source probe, and an… | 08/30/2023Open, Classified |
| Z-0038-2024 Class II | 4500MD Triple Quad Mass Spectrometer, Part Number 5032522In rare occasions, the combination of a leak of a highly flammable solvent at the ion source probe, and an… | 08/30/2023Open, Classified |
| Z-0039-2024 Class II | Citrine QTRAP Mass Spectrometer, Part Number 5063685In rare occasions, the combination of a leak of a highly flammable solvent at the ion source probe, and an… | 08/30/2023Open, Classified |