PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD v1 — Class II medical device recall Z-0513-2019
Terminated recall by PerkinElmer Health Sciences Canada, Inc., reported 2018-12-05, distributed in FL, MN, PA. Under certain conditions when using PerkinElmer QSight 210 MD mass spectrometer with Simplicity 3Q MD and Hotf
| Recall number | Z-0513-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PerkinElmer Health Sciences Canada, Inc., Bolton, N/A, Canada |
| Recall initiated | 2018-09-24 |
| Classified | 2018-11-28 |
| Reported by FDA | 2018-12-05 |
| Terminated | 2019-09-17 |
| Distributed | FL, MN, PA |
| Countries outside the US | ES, IN, IT, KR |
| Quantity | 18 units |
| Reason classes | software |
| Model numbers | BC004872 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0513-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.