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Recall Observatory FDA recall evidence

Device product

SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a clinical molecular or cytogenetics laboratory or medical research laboratory setting by knowledgeable and trained users. SoftGenomics is used to record and track activities performed in ordering, specimen processing (pre-analytical steps), testing, documentation, and reporting.

Z-2093-2021

March 31, 2021

Class II

Product summary

Firm
Soft Computer Consultants, Inc.
Event
Event 88095
Status
Terminated
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-2093-2021

Official wording

Reason: Software showing wrong results reported, PDF not match HIS.

Code information: Version 4.1.15.6

Distribution pattern: US Distribution to: CA only

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Software showing wrong results reported, PDF not match HIS.