# FDA recall Z-0513-2019

> **PerkinElmer Health Sciences Canada, Inc.** · Class II · device recall initiated 2018-09-24.

## 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.

## Distribution

FL, MN, PA  India, Italy, Korea, Spain

## Key facts

- **Recall number:** Z-0513-2019
- **Recalling firm:** PerkinElmer Health Sciences Canada, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-24
- **Report date:** 2018-12-05
- **Termination date:** 2019-09-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bolton, N/A, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0513-2019

## Citation

> AI Analytics. FDA recall Z-0513-2019. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0513-2019. Source: US FDA. Licensed CC0.

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