SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a
Summary
The FDA issued a Class II for SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and infor by Soft Computer Consultants, Inc.. Reason: Software showing wrong results reported, PDF not match HIS..
Details
Source
Device Recall
External ID
Z-2093-2021
Action Date
2021-07-28
Status
Terminated
Category
device
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.
Lot/Code Info: Version 4.1.15.6
Quantity Affected: 1
Reason for Recall
Software showing wrong results reported, PDF not match HIS.
Distribution
US Distribution to: CA only
Type: Voluntary: Firm initiated
Recall Initiated: 2021-03-31
Company
Clearwater, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 191 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Soft Computer Consultants, Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Soft Computer Consultants, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Soft Computer Consultants, Inc. have FDA actions?
Soft Computer Consultants, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2093-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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