| Class 2 Device Recall API3200MD Mass Spectrometer | |
Date Initiated by Firm | August 30, 2023 |
Date Posted | October 05, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0037-2024 |
Recall Event ID |
92810 |
Product Classification |
Mass spectrometer, clinical use - Product Code DOP
|
Product | API3200MD Mass Spectrometer, Part Number 4466230 |
Code Information |
Serial Numbers: EQ230011907, EQ230021911, EQ230001901 |
Recalling Firm/ Manufacturer |
AB Sciex, LLC 500 Old Connecticut Path Framingham MA 01701-4574
|
For Additional Information Contact | 877-740-2129 |
Manufacturer 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 2 | 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 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. |
Quantity in Commerce | 3 |
Distribution | US Nationwide. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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