Device recall: Infinite 200 The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200…

Class III FDA enforcement event 69739. Recall start date: 10 Nov 2014. Status in the FDA record: Terminated. Termination date: 21 Dec 2015.

Reason for recall, in the words of FDA

Incorrect lumi firmware version installed (E.027 instead of V2.00)

Class III, in the words of FDA

a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences

Tecan US, Inc. started this device recall on 10 Nov 2014. The firm address in the FDA record is in Morrisville, NC. FDA put the recall in Class III. FDA event 69739 has 2 product records. The first FDA enforcement report date is 21 Jan 2015. The record gives the status Terminated, with the termination date 21 Dec 2015.

FDA enforcement report The 2 product records

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 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide Distribution - USA including MD and Internationally to Hong Kong, South Korea and the UK.

Recalling firm

Tecan US, Inc., Morrisville, NC.

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

FDA records how the recall started: Voluntary: Firm initiated.

Products

2 product records in the event.

FDA event 69739: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0991-2015	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 today’s microplate applications and research and is robotic compatible. The infinite 200 has been designed as a general purpose laboratory instrument for…	8 units	Class III	Terminated	21 Jan 2015
Z-0992-2015	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 today’s microplate applications and research and is robotic compatible. The infinite 200 has been designed as a general purpose laboratory instrument…		Class III	Terminated	21 Jan 2015

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.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

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

Class III: The lowest of the three FDA recall classes.

The event in context

Device events that started in 2014: 1,176
Share of these events in Class III: 4%
Product records in this event: 2Median of the firm: 1
Events of the firm on the register: 8

Other events of the firm

Other FDA enforcement events of Tecan US, Inc.
Initiated	Product (first record)	Type	Class	Records
12 Apr 2019	Freedom EVO 200 - Product Usage: It is intended for routine laboratory tasks, such as general purpose pipetting and gene	Device	Class II	1
23 Jul 2018	Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher	Device	Class II	1
12 Jan 2018	Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva Luminescence immunoassay is intended for	Device	Class II	1
25 Jul 2016	Infinite F50 instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorba	Device	Class II	7
29 May 2015	Infinite F500, in vitro diagnostic. Product Usage: The Tecan Infinite F500 is a multifunctional microplate reader with i	Device	Class II	5
26 Sep 2014	Freedom EVO-2 100 Base Unit, with Air LiHa Arms The Freedom EVO is an open automation platform product for general labor	Device	Class II	1
19 Feb 2013	Tecan Freedom EVO with Touch Tools Suite Version 3.0 The intended use of the Touch Tools Suite is to run previously defi	Device	Class II	1

Tecan US, Inc.: all 8 events

Official channels

FDA enforcement report Z-0991-2015The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 69739. https://recallregister.com/fda/iii/69739/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide Distribution - USA including MD and Internationally to Hong Kong, South Korea and the UK.
What quantity of product is in FDA event 69739?: The event has 2 product records. The first record gives this quantity: 8 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2014 have the same class?: 4% of the 1,176 device events that started in 2014 are in Class III.