FDA-Device2018-09-26Class II
Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher
Tecan US, Inc.
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.
Sold states
Nationwide distribution to CA, MA, NC, OH, TX, and VA. Worldwide distribution to Australia, Canada, China, EU, and Japan.
Affected count
19 EVOware Sample Tracking Software Add-on
Manufactured in
9401 Globe Center Dr Ste 140, N/A, Morrisville, NC, United States
Products
Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3187-2018Don't want to check this manually?
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