Medical device recalls Moderate risk

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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