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Recall Observatory FDA recall evidence

Derived label

Device software or design

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

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
software issue
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
Tecan US, Inc.

Field note

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