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Recall Observatory FDA recall evidence

Derived label

Device software or design

ABL90 FLEX Analyzer REF 393090 UDI:05700693930909

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
software security vulnerabilities with the firm's analyzer operating system, which may cause
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
Radiometer America Inc

Field note

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