Morrisville, NC, United States
Tecan US, Inc. recalls
3 recalls recorded since 2018, most recently on 12 April 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)0
Terminated or completed3
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 12 April 2019
- Terminated
- 18 January 2022
- Reason
- 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 of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1851-2019
- 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.
Terminated Class II Medical devices
- Recall started
- 23 July 2018
- Terminated
- 26 August 2020
- Reason
- 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 Japan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3187-2018
- Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher
Terminated Class II Medical devices
- Recall started
- 12 January 2018
- Terminated
- 2 June 2020
- Reason
- 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, Finland, Switzerland, France, Austria, Denmark, Poland, Norway, Belgium, Netherlands, Italy, Canada, South Africa, Russia, and Japan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2923-2018
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.