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Recall Observatory FDA recall evidence

Derived label

Device software or design

BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
anomaly is present in InoqulA / InoqulA+ software
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
Becton Dickinson & Co.

Field note

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