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Recall Observatory FDA recall evidence

Derived label

Device software or design

Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner Label/Labeling: JADAK JDK-2330 REV B 170512-017

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
incorrect control board and firmware
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
Luminex Corporation

Field note

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