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Tecan US, Inc. recalls Infinite M1000 in vitro diagnostic. Product Usage: The Tecan Infinite M1000 is a multifunctional monochromator bas
Recalled July 8, 2015 · FDA recall Z-1969-2015 · Tecan US
Hazard
A firmware bug causes incorrect values to be displayed for specific measured luminescence values. · FDA Class II
Units
868 in total
Sold at
US Nationwide Distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NE NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, including DC
Description
A firmware bug causes incorrect values to be displayed for specific measured luminescence values.
Product
Infinite M1000 in vitro diagnostic. Product Usage: 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 a external injector module. The Infinite M1000 is intended as a general purpose laboratory instrument for professional use, supporting common microplates conforming to the ANS/SBS standards.
Manufacturer(s)
Tecan US, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →