Recall Register

Tecan US, Inc.: FDA recalls

FDA enforcement reports name Tecan US, Inc. as the recalling firm in 8 events. The events have 19 product records. The recalls started from 2013 to 2019. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

8 events, newest first.

FDA enforcement events of Tecan US, Inc.
InitiatedProduct (first record)TypeClassRecordsStatus
12 Apr 2019Freedom EVO 200 - Product Usage: It is intended for routine laboratory tasks, such as general purpose pipetting and general purpose liquid handling and robotic processes.DeviceClass II1Terminated
23 Jul 2018Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higherDeviceClass II1Terminated
12 Jan 2018Cortisol 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. The device is not intended for point-of-care…DeviceClass II1Terminated
25 Jul 2016Infinite 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 information on physiological and…DeviceClass II7Terminated
29 May 2015Infinite 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. The Infinite F500 is intended as a general…DeviceClass II5Terminated
10 Nov 2014Infinite 200 The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performance for the vast majority of today’s microplate applications and research and is robotic compatible. The infinite 200 has been designed as a general purpose laboratory instrument for…DeviceClass III2Terminated
26 Sep 2014Freedom 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.DeviceClass II1Terminated
19 Feb 2013Tecan 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 the Freedom EVO 2 instrument.DeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Tecan US, Inc.: events for each product type
TypeEvents
Device8
Tecan US, Inc.: events in each class
ClassEvents
Class II7
Class III1
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
0

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Tecan US, Inc., by the year that the recall started. The largest year is 2014, with 2 events.

Official channels

Cite this page

Recall Register. Tecan US, Inc.: FDA recalls. https://recallregister.com/firm/tecan-us-inc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
NC

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Tecan US, Inc. have?
Class II: 7 events. Class III: 1 event. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Tecan US, Inc.?
FDA event 82822, which the firm started on 12 Apr 2019. The first product in the record is: 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.
How many FDA recalls of Tecan US, Inc. have the status Ongoing?
No event has the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.