Recall Z-0513-2019 ยท DOP Mass Spectrometer, Clinical Use
PerkinElmer Health Sciences Canada, Inc.
PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD v1.0 with Hot Fix 2 Software intended to identify compounds in human samples by ionizing the compound and separating the resulting ions. Part Number: BC004872
| Date | Sep 24, 2018 |
| Status | Terminated |
| Reason | Under certain conditions when using PerkinElmer QSight 210 MD mass spectrometer with Simplicity 3Q MD and Hotfix 2 software, it is possible for the original data from the last acquired sample to be over-written when the automatic flush is enabled. |
| Root cause | Software design |
| Action | Perkin Elmer issued notification on 9/24/18 customers are requested to follow instructions contained within the Urgent Medical Device Correction letter and disseminate the information to appropriate functions within their organization. Inform relevant personnel and execute one of the following two options: Qption 1 (Users who do not require Autamatic Flushinq): Deactivate the automatic flushing option in your software: 1) Navigate to the Batch Acquisition Queue tab 2) Click the Queue Options button 3) Under the "System Flush and Standby" section, DESELECT the "Enable automatic flushing" optio |
| Quantity | 18 units |
| Distribution | FL, MN, PA India, Italy, Korea, Spain |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.