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Recall Observatory FDA recall evidence

Derived label

Device software or design

Alinity h Interface Module (HSQ)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-274-20

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
firmware and the Automation software without any error
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
Inpeco S.A.

Field note

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