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Terminated

Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher

FDA Recall Z-3187-2018 · Posted None

Recalling FirmTecan US, Inc.
Recall StatusTerminated
Product CodeJQW
Date Initiated2018-07-23
Date Terminated2020-08-26
Product Quantity19 EVOware Sample Tracking Software Add-on

Reason for Recall

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.

Firm Action

On July 23, 2018, Tecan sent Field Corrective Action Letters to their consignees advising them of the problem. Field corrections will be made in the near future.

Root Cause

Device Design

Distribution Pattern

Nationwide distribution to CA, MA, NC, OH, TX, and VA. Worldwide distribution to Australia, Canada, China, EU, and Japan.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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