Bolton, N/A, Canada
PerkinElmer Health Sciences Canada, Inc. recalls
1 recall recorded since 2018, most recently on 24 September 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 24 September 2018
- Terminated
- 17 September 2019
- 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.
- Distribution
- FL, MN, PA India, Italy, Korea, Spain
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0513-2019
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.