Tecan US Recalls
19 recalls on record · June 26, 2013 to July 3, 2019 · Medical Devices
Recalls by year
13
14
15
16
18
19
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 3, 2019Medical DevicesFDA
Tecan US, Inc. recalls Freedom EVO 200 - Product Usage: It is intended for routine laboratory tasks, such as general purpose pipetting and gene
Hazard: Gas springs not always replaced within the interval specified.
September 26, 2018Medical DevicesFDA
Tecan US, Inc. recalls Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher
Hazard: There is a software issue that can potentially impact sample identification and traceability under specific conditions when using EVOware Add On Software: Sample Tracking -Multi Instrument V1.0 or higher, Part Number 30019971.
September 5, 2018Medical DevicesFDA
Tecan US, Inc. recalls Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva Luminescence immunoassay is intended
Hazard: Product is not meeting specification for traceability to NIST cortisol standard, generating 1.3-1.8 times higher cortisol values with laboratory samples in comparison to NIST cortisol standard.
August 31, 2016Medical DevicesFDA
Tecan US, Inc. recalls Hydroflex ELISA The HYDROFLEX is a plate washer for 96-well microplates. The instrument is intended to be used primaril
Hazard: The batteries have the potential to overheating, melt or char.
August 31, 2016Medical DevicesFDA
Tecan US, Inc. recalls Tecan Infinite M1000 PRO The Tecan Infinite M1000 PRO is a multifunctional monochromator-based microplate reader that p
Hazard: The batteries have the potential to overheating, melt or char.
August 31, 2016Medical DevicesFDA
Tecan US, Inc. recalls Tecan Infinite M1000 The Tecan Infinite M1000 is a multifunctional monochromator based microplate reader that provides
Hazard: The batteries have the potential to overheating, melt or char.
August 31, 2016Medical DevicesFDA
Tecan US, Inc. recalls Infinite 200 PRO The Tecan Infinite 200 PRO is a multifunctional microplate reader with injector option. The Infinite 2
Hazard: The batteries have the potential to overheating, melt or char.
August 31, 2016Medical DevicesFDA
Tecan US, Inc. recalls Tecan Infinite 200. The SUNRISE instrument is a 96-well absorbance reader for the measurement of light absorbance (opti
Hazard: The batteries have the potential to overheating, melt or char.
August 31, 2016Medical DevicesFDA
Tecan US, Inc. recalls SUNRISE instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance
Hazard: The batteries have the potential to overheating, melt or char.
August 31, 2016Medical DevicesFDA
Tecan US, Inc. recalls Infinite F50 instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorb
Hazard: The batteries have the potential to overheating, melt or char.
July 8, 2015Medical DevicesFDA
Tecan US, Inc. recalls Infinite 200 in vitro diagnostic. Product Usage: The Tecan Infinite 200 is a multifunctional microplate reader wi
Hazard: A firmware bug causes incorrect values to be displayed for specific measured luminescence values.
July 8, 2015Medical DevicesFDA
Tecan US, Inc. recalls Infinite 200 PRO in vitro diagnostic. Product Usage: The Tecan Infinite 200 PRO is a multifunctional microplate re
Hazard: A firmware bug causes incorrect values to be displayed for specific measured luminescence values.
July 8, 2015Medical DevicesFDA
Tecan US, Inc. recalls Infinite M1000 in vitro diagnostic. Product Usage: The Tecan Infinite M1000 is a multifunctional monochromator bas
Hazard: A firmware bug causes incorrect values to be displayed for specific measured luminescence values.
July 8, 2015Medical DevicesFDA
Tecan US, Inc. recalls Infinite M1000 PRO in vitro diagnostic. Product Usage: The Tecan Infinite M1000 PRO is a multifunctional monochrom
Hazard: A firmware bug causes incorrect values to be displayed for specific measured luminescence values.
July 8, 2015Medical DevicesFDA
Tecan US, Inc. recalls Infinite F500, in vitro diagnostic. Product Usage: The Tecan Infinite F500 is a multifunctional microplate reader
Hazard: A firmware bug causes incorrect values to be displayed for specific measured luminescence values.
January 21, 2015Medical DevicesFDA
Tecan US, Inc. recalls Infinite 200PRO The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 pr
Hazard: Incorrect lumi firmware version installed (E.027 instead of V2.00)
January 21, 2015Medical DevicesFDA
Tecan US, Inc. recalls Infinite 200 The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provi
Hazard: Incorrect lumi firmware version installed (E.027 instead of V2.00)
November 5, 2014Medical DevicesFDA
Tecan US, Inc. recalls Freedom EVO-2 100 Base Unit, with Air LiHa Arms The Freedom EVO is an open automation platform product for general la
Hazard: Distortion (noise interference) of the liquid level capacitance can result in air aspiration instead of liquid aspiration. This might cause a false signal (air detection) with possible dispense errors resulting in erroneous results.
June 26, 2013Medical DevicesFDA
Tecan US, Inc. recalls Tecan Freedom EVO with Touch Tools Suite Version 3.0 The intended use of the Touch Tools Suite is to run previously
Hazard: WIth TouchTools 3.0 after the execution of a Rich User Prompt in Display and Wait mode, door lock errors are ignored. If an operator presses "Continue" following a Rich User Prompt and the door has been left open, the script will progress (continue without warning). This could lead to the instrument moving unexpectedly and potentially cause an injury to the operator if they are physically inside t