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Tecan US, Inc.

FDA Regulatory Profile

Summary

Total Recalls
19
510(k) Clearances
0
Inspections
1
Compliance Actions
0

Known Names

tecan us, tecan u.s

Recent Recalls

NumberClassProductDate
Z-1851-2019Class IIFreedom EVO 200 - Product Usage: It is intended for routine laboratory tasks, such as general purposApril 12, 2019
Z-3187-2018Class IIFreedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higherJuly 23, 2018
Z-2923-2018Class IICortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva Luminescence immuJanuary 12, 2018
Z-2664-2016Class IITecan Infinite M1000 The Tecan Infinite M1000 is a multifunctional monochromator based microplate rJuly 25, 2016
Z-2666-2016Class IIHydroflex ELISA The HYDROFLEX is a plate washer for 96-well microplates. The instrument is intendedJuly 25, 2016
Z-2665-2016Class IITecan Infinite M1000 PRO The Tecan Infinite M1000 PRO is a multifunctional monochromator-based micrJuly 25, 2016
Z-2663-2016Class IIInfinite 200 PRO The Tecan Infinite 200 PRO is a multifunctional microplate reader with injector opJuly 25, 2016
Z-2661-2016Class IISUNRISE instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement July 25, 2016
Z-2660-2016Class IIInfinite F50 instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measureJuly 25, 2016
Z-2662-2016Class IITecan Infinite 200. The SUNRISE instrument is a 96-well absorbance reader for the measurement of liJuly 25, 2016
Z-1967-2015Class IIInfinite F500, in vitro diagnostic. Product Usage: The Tecan Infinite F500 is a multifunctionaMay 29, 2015
Z-1971-2015Class IIInfinite 200 in vitro diagnostic. Product Usage: The Tecan Infinite 200 is a multifunctional May 29, 2015
Z-1970-2015Class IIInfinite 200 PRO in vitro diagnostic. Product Usage: The Tecan Infinite 200 PRO is a multifuncMay 29, 2015
Z-1968-2015Class IIInfinite M1000 PRO in vitro diagnostic. Product Usage: The Tecan Infinite M1000 PRO is a multiMay 29, 2015
Z-1969-2015Class IIInfinite M1000 in vitro diagnostic. Product Usage: The Tecan Infinite M1000 is a multifunctionMay 29, 2015
Z-0992-2015Class IIIInfinite 200PRO The Tecan Infinite 200 is a multifunctional microplate reader with injector option.November 10, 2014
Z-0991-2015Class IIIInfinite 200 The Tecan Infinite 200 is a multifunctional microplate reader with injector option. ThNovember 10, 2014
Z-0149-2015Class IIFreedom EVO-2 100 Base Unit, with Air LiHa Arms The Freedom EVO is an open automation platform prSeptember 26, 2014
Z-1560-2013Class IITecan Freedom EVO with Touch Tools Suite Version 3.0 The intended use of the Touch Tools Suite iFebruary 19, 2013