Home / Recalls / Medical Devices
Tecan US, Inc. recalls Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher
Recalled September 26, 2018 · FDA recall Z-3187-2018 · Tecan US
Hazard
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. · FDA Class II
Units
19 EVOware Sample Tracking Software Add-on
Sold at
Nationwide distribution to CA, MA, NC, OH, TX, and VA. Worldwide distribution to Australia, Canada, China, EU, and Japan.
Description
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.
Product
Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher
Manufacturer(s)
Tecan US, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →