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Recall Observatory FDA recall evidence

Derived label

Device software or design

BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL containing software version 3.5.3.1

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
software version 3.5.3.1 may move with random speeds in random direction across its range of motion. This could result in
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
Biocare Medical, LLC

Field note

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