The Recall Desk

Manufacturer

Tecan US, Inc.

19 recalls in our database name Tecan US, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
19
Critical
0
Severe
7
Most recent
2019-07-03

Of the 19 recalls from Tecan US, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 7 (37%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–19 of 19

  • ModerateFDA (Devices)·Z-1851-2019·2019-07-03

    Tecan Freedom EVO 200 Laboratory Robots Recalled for Gas Spring Maintenance

    Tecan US, Inc. is recalling 40 Freedom EVO 200 laboratory robots because gas springs were not always replaced within the specified interval.

    Product
    Freedom EVO 200 - Product Usage: It is intended for routine laboratory tasks, such as general purpose pipetting and general purpose liquid handling and robotic processes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3187-2018·2018-09-26

    Tecan Freedom EV0-2 Software Recall for Sample Tracking Issues

    Tecan US, Inc. is recalling Freedom EV0-2 devices with EVOware Sample Tracking Add-On V1.0 or higher due to a software issue that can impact sample identification and traceability.

    Product
    Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2923-2018·2018-09-05

    Tecan Recalls Cortisol Saliva Luminescence Immunoassay Kits for Inaccurate Results

    Tecan US, Inc. is recalling specific lots of the IBL International Cortisol Saliva Luminescence Immunoassay because the product generates cortisol values 1.3 to 1.8 times higher than the NIST standard.

    Product
    Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva Luminescence immunoassay is intended for the in-vitro diagnostic quantitative determination of Cortisol in human saliva and for use as an aid in the diagnosis and treatment of adrenal disorders. Th
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Devices)·Z-2660-2016·2016-08-31

    Tecan Infinite F50 Absorbance Reader Recalled for Battery Overheating Risk

    Tecan US, Inc. is recalling Infinite F50 absorbance readers because the batteries may overheat, melt, or char.

    Product
    Infinite F50 instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2665-2016·2016-08-31

    Tecan Infinite M1000 PRO Microplate Reader Recalled for Battery Overheating Risk

    Tecan US, Inc. is recalling 11 Infinite M1000 PRO microplate readers because their batteries may overheat, melt, or char.

    Product
    Tecan Infinite M1000 PRO The Tecan Infinite M1000 PRO is a multifunctional monochromator-based microplate reader that provides high performance for the vast majority of todays microplate applications and research. In addition to offering absorbance and fluorescence intensity mea
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2662-2016·2016-08-31

    Tecan Infinite 200 Absorbance Reader Recalled for Battery Overheating Risk

    Tecan US, Inc. is recalling 5 units of the Tecan Infinite 200 absorbance reader because the batteries may overheat, melt, or char.

    Product
    Tecan Infinite 200. The SUNRISE instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain informati
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2661-2016·2016-08-31

    Tecan INFINITE F50 Absorbance Reader Recalled for Battery Overheating Risk

    Tecan US, Inc. is recalling 19 INFINITE F50 absorbance readers because the batteries may overheat, melt, or char.

    Product
    SUNRISE instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain info
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2664-2016·2016-08-31

    Tecan Infinite M1000 Microplate Reader Recalled for Battery Overheating Risk

    Tecan US, Inc. is recalling the Infinite M1000 microplate reader because its batteries may overheat, melt, or char.

    Product
    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
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2666-2016·2016-08-31

    Tecan Hydroflex ELISA Plate Washer Recalled for Battery Overheating Risk

    Tecan US, Inc. is recalling Hydroflex ELISA plate washers because the batteries may overheat, melt, or char.

    Product
    Hydroflex ELISA The HYDROFLEX is a plate washer for 96-well microplates. The instrument is intended to be used primarily in in-vitro diagnostic processing of samples from the human body to obtain information on physiological and pathological states. Software and instrument have
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2663-2016·2016-08-31

    Tecan Infinite 200 PRO Microplate Reader Recalled for Battery Overheating

    Tecan US, Inc. is recalling 27 Infinite 200 PRO microplate readers because the batteries may overheat, melt, or char.

    Product
    Infinite 200 PRO The Tecan Infinite 200 PRO is a multifunctional microplate reader with injector option. The Infinite 200 PRO provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The Infinite 200 PRO has been d
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-1969-2015·2015-07-08

    Tecan Infinite M1000 Microplate Reader Recalled for Firmware Bug

    Tecan US, Inc. is recalling 868 Infinite M1000 microplate readers because a firmware bug causes incorrect luminescence values to be displayed.

    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 fluor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1968-2015·2015-07-08

    Tecan Infinite M1000 PRO Microplate Reader Recalled for Firmware Bug

    Tecan US, Inc. is recalling 868 Infinite M1000 PRO microplate readers because a firmware bug causes incorrect luminescence values to be displayed.

    Product
    Infinite M1000 PRO in vitro diagnostic. Product Usage: The Tecan Infinite M1000 PRO is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays microplate applications and research. In addition to offering absor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1967-2015·2015-07-08

    Tecan Infinite F500 Microplate Reader Recalled for Firmware Bug

    Tecan US, Inc. is recalling 868 Infinite F500 microplate readers because a firmware bug causes incorrect luminescence values to be displayed.

    Product
    Infinite F500, in vitro diagnostic. Product Usage: The Tecan Infinite F500 is a multifunctional microplate reader with injector option. The Infinite F500 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1970-2015·2015-07-08

    Tecan Infinite 200 PRO Microplate Reader Recalled for Firmware Bug

    Tecan US, Inc. is recalling 868 Infinite 200 PRO microplate readers because a firmware bug causes incorrect luminescence values to be displayed.

    Product
    Infinite 200 PRO in vitro diagnostic. Product Usage: The Tecan Infinite 200 PRO is a multifunctional microplate reader with injector option. The Infinite 200 PRO provides high performance for the vast majority of todays microplate applications and research and is robotic c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1971-2015·2015-07-08

    Tecan Infinite 200 Microplate Reader Recalled for Firmware Bug

    Tecan US, Inc. is recalling 868 Infinite 200 microplate readers because a firmware bug causes incorrect luminescence values to be displayed.

    Product
    Infinite 200 in vitro diagnostic. Product Usage: The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0992-2015·2015-01-21

    Tecan Infinite 200PRO Microplate Reader Recalled for Firmware Error

    Tecan US, Inc. is recalling Infinite 200PRO microplate readers due to an incorrect firmware version installed on the devices.

    Product
    Infinite 200PRO The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The infinite 200 has been designed as a
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0991-2015·2015-01-21

    Tecan Infinite 200 Microplate Reader Recalled for Incorrect Firmware Version

    Tecan US, Inc. is recalling eight Infinite 200 microplate readers because they were shipped with the incorrect lumi firmware version (E.027 instead of V2.00).

    Product
    Infinite 200 The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The infinite 200 has been designed as a ge
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0149-2015·2014-11-05

    Tecan Freedom EVO-2 100 Base Unit Recalled for Liquid Level Interference

    Tecan US, Inc. is recalling two Freedom EVO-2 100 Base Units because noise interference may cause air aspiration instead of liquid, leading to erroneous laboratory results.

    Product
    Freedom EVO-2 100 Base Unit, with Air LiHa Arms The Freedom EVO is an open automation platform product for general laboratory use. It is intended for routine laboratory tasks, such as general purpose pipetting and general purpose liquid handling and robotic processes.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1560-2013·2013-06-26

    Tecan Freedom EVO Software Recall for Door Lock Safety Defect

    Tecan US, Inc. is recalling 12 Freedom EVO instruments with Touch Tools Suite 3.0 because door lock errors are ignored, potentially causing unexpected movement and operator injury.

    Product
    Tecan Freedom EVO with Touch Tools Suite Version 3.0 The intended use of the Touch Tools Suite is to run previously defined scripts and processes on a Freedom EVO platform (Touch Tools Suite is an optional software add-on for Freedom EVOware (the base operational software for
    Category
    Medical Device
    Distribution
    Distributed nationwide