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Recall Observatory FDA recall evidence

Derived label

Device software or design

RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
software could
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
Randox Laboratories

Field note

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