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Recall Observatory FDA recall evidence

Derived label

Device software or design

Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
software included in specific lots of VARIANT nbs Sickle Cell Progam Reorder Pack causes
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
Bio-Rad Laboratories, Inc.

Field note

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