Medical device recalls Moderate risk

Tecan US product recalled over fire hazard

Recall date
July 25, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Tecan US, Inc. recalls Tecan Infinite M1000 The Tecan Infinite M1000 is a multifunctional monochromator based microplate reader that provides…
Recall number
Z-2664-2016
FDA classification
Class II
Brand / firm
Tecan US, Inc.
Sold / distributed
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.

Why it was recalled

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

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

What was recalled

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

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