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Recall Observatory FDA recall evidence

Device 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

Z-0513-2019

September 24, 2018

Class II

Product summary

Firm
PerkinElmer Health Sciences Canada, Inc.
Event
Event 81266
Status
Terminated
Classification
Class II
Quantity
18 units
Official record key
device-enforcement:Z-0513-2019

Official wording

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.

Code information: 210MDBC709100008 210MD8C709140010 210MD8C709150009 210MDBC709160011 210MDBC709180012 210MDBC709200013 210MD8C710020014 210MDBC710050016 210MD8C710110018 210MDBC710170020 210MD8C710180022 210MD8C712220428 210MDBC801240030 210MDBC801250031 210MDBC802140032 210MD8C802150033 210MD8C802260035 210MDBC803190037

Distribution pattern: FL, MN, PA India, Italy, Korea, Spain

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.