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Recall Observatory FDA recall evidence

Device product

Tecan Infinite M1000 The Tecan Infinite M1000 is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays microplate applications and research. Besides offering absorbance and fluorescence intensity measurements, the Infinite M1000 allows the measurement of fluorescence polarization and luminescence. The Infinite M1000 is also robotic compatible and offers a built-in stacker option as well as an external injector module. The Infinite M1000 is intended as a general purpose laboratory instrument for professional use, supporting common microplates conforming to the ANSI/SBS standards

Z-2664-2016

July 25, 2016

Class II

Product summary

Firm
Tecan US, Inc.
Event
Event 74806
Status
Terminated
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-2664-2016

Official wording

Reason: The batteries have the potential to overheating, melt or char.

Code information: Instrument Material #30034301, PC Serial number: 2CE33625NS, Instrument Serial #1508007738.

Distribution pattern: Worldwide Distribution - US including AK, AL, AR, CA, FL, GA, HI, KY, MA, MD, NC, NY, PA, PR, SC, TN, TX, UT, VA. International account: Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The batteries have the potential to overheating, melt or char.