Reported Sep 26, 2018 · Terminated
Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher
Tecan US, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tecan US, Inc. · 9401 Globe Center Dr Ste 140 · Morrisville, NC · 27560-6211
Is this the product you have?
- Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher
- Lot codes and dates
3 of 3 products
Products covered by this recall # Product as published 1 Freedom EVO 100: 10641100, 30020010, 30032010 2 Freedom EVO 150: 10641150, 10641152, 30020015, 30032015 3 Freedom EVO 200 Base Unit: 10641200, 10641202, 30020020, 30032020; Part Numbers for Software: EVOware Sample Tracking Add-On for Multi¿ Instrument Configurations: 30019971; Serial Numbers for device: 1302001540, 1708006808, 1208007284, 1503007126, 1503007304, 905000588, 1205002755, 1205002802, 1305007607, 1308005431, 1310005144, 1310005145, 905000587, 1705007973, 904000335, 1510009082, 1109004352, 1704005194, 1007000504, 1305002594, 1307006551 and 1105004439. - Amount recalled
- 19 EVOware Sample Tracking Software Add-on
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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