Tecan US, Inc.

Medical device manufacturer in Morrisville, NC.

0510(k) clearances
0PMA approvals
19recalls

Recalls

RecallProductInitiated
Z-1851-2019 Class IIFreedom EVO 200 - Product Usage: It is intended for routine laboratory tasks, such as…Gas springs not always replaced within the interval specified. 04/12/2019Terminated
Z-3187-2018 Class IIFreedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or…There is a software issue that can potentially impact sample identification and traceability under specific… 07/23/2018Terminated
Z-2923-2018 Class IICortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva…Product is not meeting specification for traceability to NIST cortisol standard, generating 1.3-1.8 times… 01/12/2018Terminated
Z-2666-2016 Class IIHydroflex ELISA The HYDROFLEX is a plate washer for 96-well microplates. The instrument…The batteries have the potential to overheating, melt or char. 07/25/2016Terminated
Z-2665-2016 Class IITecan Infinite M1000 PRO The Tecan Infinite M1000 PRO is a multifunctional…The batteries have the potential to overheating, melt or char. 07/25/2016Terminated
Z-2664-2016 Class IITecan Infinite M1000 The Tecan Infinite M1000 is a multifunctional monochromator based…The batteries have the potential to overheating, melt or char. 07/25/2016Terminated
Z-2663-2016 Class IIInfinite 200 PRO The Tecan Infinite 200 PRO is a multifunctional microplate reader with…The batteries have the potential to overheating, melt or char. 07/25/2016Terminated
Z-2662-2016 Class IITecan Infinite 200. The SUNRISE instrument is a 96-well absorbance reader for the…The batteries have the potential to overheating, melt or char. 07/25/2016Terminated
Z-2661-2016 Class IISUNRISE instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the…The batteries have the potential to overheating, melt or char. 07/25/2016Terminated
Z-2660-2016 Class IIInfinite F50 instrument. The INFINITE F50 instrument is a 96-well absorbance reader for…The batteries have the potential to overheating, melt or char. 07/25/2016Terminated
Z-1971-2015 Class IIInfinite 200 in vitro diagnostic. Product Usage: The Tecan Infinite 200 is a…A firmware bug causes incorrect values to be displayed for specific measured luminescence values. 05/29/2015Terminated
Z-1970-2015 Class IIInfinite 200 PRO in vitro diagnostic. Product Usage: The Tecan Infinite 200 PRO is a…A firmware bug causes incorrect values to be displayed for specific measured luminescence values. 05/29/2015Terminated
Z-1969-2015 Class IIInfinite M1000 in vitro diagnostic. Product Usage: The Tecan Infinite M1000 is a…A firmware bug causes incorrect values to be displayed for specific measured luminescence values. 05/29/2015Terminated
Z-1968-2015 Class IIInfinite M1000 PRO in vitro diagnostic. Product Usage: The Tecan Infinite M1000 PRO is a…A firmware bug causes incorrect values to be displayed for specific measured luminescence values. 05/29/2015Terminated
Z-1967-2015 Class IIInfinite F500, in vitro diagnostic. Product Usage: The Tecan Infinite F500 is a…A firmware bug causes incorrect values to be displayed for specific measured luminescence values. 05/29/2015Terminated
Z-0992-2015 Class IIIInfinite 200PRO The Tecan Infinite 200 is a multifunctional microplate reader with…Incorrect lumi firmware version installed (E.027 instead of V2.00) 11/10/2014Terminated
Z-0991-2015 Class IIIInfinite 200 The Tecan Infinite 200 is a multifunctional microplate reader with injector…Incorrect lumi firmware version installed (E.027 instead of V2.00) 11/10/2014Terminated
Z-0149-2015 Class IIFreedom EVO-2 100 Base Unit, with Air LiHa Arms The Freedom EVO is an open automation…Distortion (noise interference) of the liquid level capacitance can result in air aspiration instead of… 09/26/2014Terminated
Z-1560-2013 Class IITecan Freedom EVO with Touch Tools Suite Version 3.0 The intended use of the Touch Tools…WIth TouchTools 3.0 after the execution of a Rich User Prompt in Display and Wait mode, door lock errors are… 02/19/2013Terminated