Derived label
Device software or design
BD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing Catalog Number : 447213
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.