Recall Z-3187-2018— Tecan US, Inc.
Class II · Terminated
Class II FDA medical device recall by Tecan US, Inc., initiated 2018-07-23, terminated 2020-08-26. FDA's recall record names no specific 510(k) clearance for this event. Product: Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher. Reason: 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..
- Recalling firm
- Tecan US, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-07-23
- Terminated
- 2020-08-26
- Firm location
- Morrisville, NC, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.