Derived label
Device software or design
BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202
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.