Nov

2018

Recall – Mass Spectrometer software allows data to be overwritten under certain conditions

Company: PerkinElmer Health Sciences Canada, Inc.
Date of Enforcement Report: 11/28/2018
Class II:

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

Recall Number: Z-0513-2019

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.

RECALLING FIRM/MANUFACTURER
PerkinElmer Health Sciences Canada, Inc., Bolton, Canada on 9/24/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
18 units

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

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Recall – Mass Spectrometer software allows data to be overwritten under certain conditions

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