Tecan US, Inc. recalls Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher
- Recall date
- July 23, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-3187-2018
- FDA classification
- Class II
- Brand / firm
- Tecan US, Inc.
- Sold / distributed
- Nationwide distribution to CA, MA, NC, OH, TX, and VA. Worldwide distribution to Australia, Canada, China, EU, and Japan.
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher
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