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Recall Observatory FDA recall evidence

Derived label

Device software or design

VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
software version, the user could
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
Ortho-Clinical Diagnostics, Inc.

Field note

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