FDA Device recall 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 b…
- FDA Device
- Class II
- terminated
- Published 2018-12-05
On 2018-12-05 the FDA classified a Class II recall of PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD v1.0 with Hot Fix 2 Software intended to identify compounds in human samples b… by Perkinelmer Health Sciences Canada, citing 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 acq….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0513-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-09-24 |
| Published | 2018-12-05 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Perkinelmer Health Sciences Canada |
| Distribution | FL, MN, PA |
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.
Identifiers
| code_info | 210MDBC709100008 210MD8C709140010 210MD8C709150009 210MDBC709160011 210MDBC709180012 210MDBC709200013 210MD8C7100…210MDBC709100008 210MD8C709140010 210MD8C709150009 210MDBC709160011 210MDBC709180012 210MDBC709200013 210MD8C710020014 210MDBC710050016 210MD8C710110018 210MDBC710170020 210MD8C710180022 210MD8C712220428 210MDBC801240030 210MDBC801250031 210MDBC802140032 210MD8C802150033 210MD8C802260035 210MDBC803190037 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0513-2019%22
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