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Recall Observatory FDA recall evidence

Derived label

Device software or design

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
firmware version 1.1.0.0 can cause sub-system communication failures. This failure could result in
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
Beckman Coulter, Inc.

Field note

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