Recall Z-0039-2024 ยท DOP Mass Spectrometer, Clinical Use
AB Sciex, LLC
Citrine QTRAP Mass Spectrometer, Part Number 5063685
| Date | Oct 5, 2023 (initiated Aug 30, 2023) |
| Status | Open, Classified |
| 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 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. |
| Root cause | 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 prob |
| Quantity | 10 |
| Distribution | US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.