PerkinElmer Health Sciences Canada, Inc. recalls PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD v1.0 with Hot Fix 2 Software intended to identify compound…

Recall date

September 24, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0513-2019

FDA classification

Class II

Brand / firm

PerkinElmer Health Sciences Canada, Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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