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Tecan U.S., Ltd.

Also registered as Tecan U.S., Inc.

Country not established

Devices
10
FDA recalls
22

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Tecan U.S., Ltd. makes

Tecan U.S., Ltd. makes laboratory equipment, including microplate washers and robotic sample processors. Their products include the SLT Microplate Washer, Profiblot, and various models of the Robotic Sample Processor.

The company's portfolio is regulated as Class I devices and is listed in the FDA 510(k) registry. The company is based in the US.

AI-generated from registry data, 30 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue10

Newest first, rows 1-10 of 10

  • 4 Channel Dispenser Ref K944556

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Slt Microplate Washer Ref K910740

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Tecan Robotic Sample Processor(Rsp) #500 Ref K854406

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Profiblot Ref K933996

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • 4 Channel Dispenser Ref K942655

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Rsp Mega Sample Processor Ref K915492

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Genesis Rmp Ref K963268

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Robotic Sample Processor Ref K894126

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Genesis Ref K953345

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Robotic Sample Processor Ref K912036

    Active Regimes: 510(k) Registry: 510(k) Class:I

FDA recalls22

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

Recalls initiated per year

  • 2017 0
  • 2018 2
  • 2019 1
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

19 initiated before 2017

Showing the 10 most recent of 22 recalls.

  • 2019

    • 12 Apr 2019 Z-1851-2019 Class II Terminated Gas springs not always replaced within the interval specified. Distribution: Worldwide distribution. US Nationwide distribution in the states CA, CO, CT, KS, NC, NJ, OR, RI, TN, TX, and VA. Country…
      Full distribution text Worldwide distribution. US Nationwide distribution in the states CA, CO, CT, KS, NC, NJ, OR, RI, TN, TX, and VA. Country of Canada.

  • 2018

    • 23 Jul 2018 Z-3187-2018 Class II Terminated 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. Distribution: Nationwide distribution to CA, MA, NC, OH, TX, and VA. Worldwide distribution to Australia, Canada, China, EU, and…
      Full distribution text Nationwide distribution to CA, MA, NC, OH, TX, and VA. Worldwide distribution to Australia, Canada, China, EU, and Japan.
    • 12 Jan 2018 Z-2923-2018 Class II Terminated 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. Distribution: Worldwide distribution; US distribution to states of: GA, IA, LA, MA, MN, OR, PA, SC, and UT; and countries of: Germany,…
      Full distribution text Worldwide distribution; US distribution to states of: GA, IA, LA, MA, MN, OR, PA, SC, and UT; and countries of: Germany, Finland, Switzerland, France, Austria, Denmark, Poland, Norway, Belgium, Netherlands, Italy, Canada, South Africa, Russia, and Japan.
      Submission number: K150528

  • 2016

    • 25 Jul 2016 Z-2660-2016 Class II Terminated The batteries have the potential to overheating, melt or char. Distribution: Worldwide Distribution - US including AK, AL, AR, CA, FL, GA, HI, KY, MA, MD, NC, NY, PA, PR, SC, TN, TX, UT, VA.…
      Full distribution text Worldwide Distribution - US including AK, AL, AR, CA, FL, GA, HI, KY, MA, MD, NC, NY, PA, PR, SC, TN, TX, UT, VA. International account: Canada.
    • 25 Jul 2016 Z-2661-2016 Class II Terminated The batteries have the potential to overheating, melt or char. Distribution: Worldwide Distribution - US including AK, AL, AR, CA, FL, GA, HI, KY, MA, MD, NC, NY, PA, PR, SC, TN, TX, UT, VA.…
      Full distribution text Worldwide Distribution - US including AK, AL, AR, CA, FL, GA, HI, KY, MA, MD, NC, NY, PA, PR, SC, TN, TX, UT, VA. International account: Canada.
    • 25 Jul 2016 Z-2662-2016 Class II Terminated The batteries have the potential to overheating, melt or char. Distribution: Worldwide Distribution - US including AK, AL, AR, CA, FL, GA, HI, KY, MA, MD, NC, NY, PA, PR, SC, TN, TX, UT, VA.…
      Full distribution text Worldwide Distribution - US including AK, AL, AR, CA, FL, GA, HI, KY, MA, MD, NC, NY, PA, PR, SC, TN, TX, UT, VA. International account: Canada.
    • 25 Jul 2016 Z-2663-2016 Class II Terminated The batteries have the potential to overheating, melt or char. Distribution: Worldwide Distribution - US including AK, AL, AR, CA, FL, GA, HI, KY, MA, MD, NC, NY, PA, PR, SC, TN, TX, UT, VA.…
      Full distribution text Worldwide Distribution - US including AK, AL, AR, CA, FL, GA, HI, KY, MA, MD, NC, NY, PA, PR, SC, TN, TX, UT, VA. International account: Canada.
    • 25 Jul 2016 Z-2664-2016 Class II Terminated The batteries have the potential to overheating, melt or char. Distribution: Worldwide Distribution - US including AK, AL, AR, CA, FL, GA, HI, KY, MA, MD, NC, NY, PA, PR, SC, TN, TX, UT, VA.…
      Full distribution text Worldwide Distribution - US including AK, AL, AR, CA, FL, GA, HI, KY, MA, MD, NC, NY, PA, PR, SC, TN, TX, UT, VA. International account: Canada.
    • 25 Jul 2016 Z-2665-2016 Class II Terminated The batteries have the potential to overheating, melt or char. Distribution: Worldwide Distribution - US including AK, AL, AR, CA, FL, GA, HI, KY, MA, MD, NC, NY, PA, PR, SC, TN, TX, UT, VA.…
      Full distribution text Worldwide Distribution - US including AK, AL, AR, CA, FL, GA, HI, KY, MA, MD, NC, NY, PA, PR, SC, TN, TX, UT, VA. International account: Canada.
    • 25 Jul 2016 Z-2666-2016 Class II Terminated The batteries have the potential to overheating, melt or char. Distribution: Worldwide Distribution - US including AK, AL, AR, CA, FL, GA, HI, KY, MA, MD, NC, NY, PA, PR, SC, TN, TX, UT, VA.…
      Full distribution text Worldwide Distribution - US including AK, AL, AR, CA, FL, GA, HI, KY, MA, MD, NC, NY, PA, PR, SC, TN, TX, UT, VA. International account: Canada.
Show all 22 recalls

  • 2015

    • 29 May 2015 Z-1967-2015 Class II Terminated A firmware bug causes incorrect values to be displayed for specific measured luminescence values. Distribution: 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,…
      Full distribution text 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
    • 29 May 2015 Z-1968-2015 Class II Terminated A firmware bug causes incorrect values to be displayed for specific measured luminescence values. Distribution: 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,…
      Full distribution text 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
    • 29 May 2015 Z-1969-2015 Class II Terminated A firmware bug causes incorrect values to be displayed for specific measured luminescence values. Distribution: 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,…
      Full distribution text 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
    • 29 May 2015 Z-1970-2015 Class II Terminated A firmware bug causes incorrect values to be displayed for specific measured luminescence values. Distribution: 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,…
      Full distribution text 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
    • 29 May 2015 Z-1971-2015 Class II Terminated A firmware bug causes incorrect values to be displayed for specific measured luminescence values. Distribution: 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,…
      Full distribution text 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

  • 2014

    • 10 Nov 2014 Z-0991-2015 Class III Terminated Incorrect lumi firmware version installed (E.027 instead of V2.00) Distribution: Worldwide Distribution - USA including MD and Internationally to Hong Kong, South Korea and the UK.
    • 10 Nov 2014 Z-0992-2015 Class III Terminated Incorrect lumi firmware version installed (E.027 instead of V2.00) Distribution: Worldwide Distribution - USA including MD and Internationally to Hong Kong, South Korea and the UK.
    • 26 Sep 2014 Z-0149-2015 Class II Terminated 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. Distribution: US Distribution to IL.

  • 2013

    • 19 Feb 2013 Z-1560-2013 Class II Terminated 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 Distribution: Worldwide distribution: US (nationwide) including states of: CA, KY, NC, OH, TX, and WI; and countries of: France,…
      Full distribution text Worldwide distribution: US (nationwide) including states of: CA, KY, NC, OH, TX, and WI; and countries of: France, Germany and Italy.

  • 2005

    • 11 Apr 2005 Z-0326-06 Unclassified (pre-2012) Terminated Double filtering of 1000 l tips. The defect could result in cross contamination of other samples due to possible dripping of sample while moving over other samples. Distribution: IL and Europe

  • 2004

    • 3 May 2004 Z-1022-04 Unclassified (pre-2012) Terminated Tecan software has the potential to match the patient with a different patient's test results. Distribution: CA, CT, GA, IL, IN, MA, MD, MI, NJ, NY, PA, TN, TX, VA, & WI. Submission number: K953345

  • 2003

    • 27 Feb 2003 Z-0869-03 Unclassified (pre-2012) Terminated Firmware defect. Under certain conditions a strip rack is no longer in the initial position after a motor overload of the barcode scanner PosID2. Distribution: Instruments requiring upgrade were distributed to various clinical laboratories and blood banks Nationwide and World…
      Full distribution text Instruments requiring upgrade were distributed to various clinical laboratories and blood banks Nationwide and World wide .
      Submission number: K953345

Frequently asked questions

How many devices does Tecan U.S., Ltd. have in the registry?

The registry currently lists 10 devices for Tecan U.S., Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Tecan U.S., Ltd.'s devices?

Among its 10 most recently registered devices, Tecan U.S., Ltd. has devices listed in FDA 510(k) (10 devices).

What risk classes do Tecan U.S., Ltd.'s devices fall under?

Among its 10 most recently registered devices, the classes recorded for Tecan U.S., Ltd.'s devices are Class I. Each device page shows its own class and authorisation.

Are there FDA recall records for Tecan U.S., Ltd.?

FDA recall records list 22 recalls initiated by Tecan U.S., Ltd., the most recent initiated on 12 Apr 2019. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Tecan U.S., Ltd. in the registry?

The most recently registered devices listed for Tecan U.S., Ltd. include 4 CHANNEL DISPENSER, SLT MICROPLATE WASHER, TECAN ROBOTIC SAMPLE PROCESSOR(RSP) #500 and PROFIBLOT.

Generated automatically from registry data and not verified by a human reviewer.