FDA-Device2018-12-05Class II

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

PerkinElmer Health Sciences Canada, Inc.
Hazard

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.

Sold states
FL, MN, PA India, Italy, Korea, Spain
Affected count
18 units
Manufactured in
32 Nixon Rd Unit 1, N/A, Bolton, N/A, Canada
Products
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

Official notice

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

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