Recall Z-0513-2019— PerkinElmer Health Sciences Canada, Inc.
Class II · Terminated
Class II FDA medical device recall by PerkinElmer Health Sciences Canada, Inc., initiated 2018-09-24, terminated 2019-09-17. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. 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..
- Recalling firm
- PerkinElmer Health Sciences Canada, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-09-24
- Terminated
- 2019-09-17
- Firm location
- Bolton, N/A, Canada
Product description
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
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.