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.
Reported: July 28, 2021 Initiated: March 31, 2021 #Z-2093-2021
Product Description
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.
Reason for Recall
Software showing wrong results reported, PDF not match HIS.
Details
- Recalling Firm
- Soft Computer Consultants, Inc.
- Units Affected
- 1
- Distribution
- US Distribution to: CA only
- Location
- Clearwater, FL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Soft Computer Consultants, Inc.. Units affected: 1.
Why was this product recalled? ▼
Software showing wrong results reported, PDF not match HIS.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 28, 2021. Severity: Moderate. Recall number: Z-2093-2021.
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