FDA recall Z-3187-2018

Product

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

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2018-07-23

Report date

2018-09-26

Termination date

2020-08-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morrisville, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3187-2018