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Recall Observatory FDA recall evidence

Derived label

Device software or design

Alinity ci-series System Control Module, REF: 03R70-01

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
software versions 3.4.0 and lower, including: 1) SCC Reagent load error
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
Abbott Laboratories

Field note

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