Reported Dec 5, 2018 · Terminated

PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD v1.0 with Hot Fix 2 Software intended to identify…

PerkinElmer Health Sciences Canada, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: PerkinElmer Health Sciences Canada, Inc. · 32 Nixon Rd Unit 1 · Bolton, N/A · N/A

Is this the product you have?

  • 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 NumberBC004872
Lot codes and dates
    • 210MDBC709100008
    • 210MD8C709140010
    • 210MD8C709150009
    • 210MDBC709160011
    • 210MDBC709180012
    • 210MDBC709200013
    • 210MD8C710020014
    • 210MDBC710050016
    • 210MD8C710110018
    • 210MDBC710170020
    • 210MD8C710180022
    • 210MD8C712220428
    • 210MDBC801240030
    • 210MDBC801250031
    • 210MDBC802140032
    • 210MD8C802150033
    • 210MD8C802260035
    • 210MDBC803190037
Amount recalled
18 units

Where it was sold

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 17, 2019 · Data as of Sep 19, 5:36 PM UTC

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