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U.S. Department of Health and Human Services

Class 2 Device Recall SoftLab

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  Class 2 Device Recall SoftLab see related information
Date Initiated by Firm May 03, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on August 07, 2013
Recall Number Z-0488-2012
Recall Event ID 60452
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product SoftLab GUI versions:;;;;;;;; and

Product Usage: SoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and reporting laboratory data.
Code Information SoftLab GUI versions:;;;;;;;; and
Recalling Firm/
SCC Soft Computer
5400 Tech Data Drive
Clearwater FL 33760
For Additional Information Contact Kathryn Branca
Manufacturer Reason
for Recall
On 05/03/2011, SCC Soft Computer, Clearwater, FL, initiated a correction on the following SoftLab GUI versions:;;;;;;;; and A client reported that results were not flagged correctly. This can occur when a test is ordered in Order Entry, then collected
FDA Determined
Cause 2
Software design
Action SCC Soft Computer sent a "CORRECTION COMMUNICATION" notification letter to all affected customers. The letter describes the product, Risk-to-Health notification task, potential hazard, and corrective action. The customers were asked to acknowledge receipt of the task and grant permission for SCC to make the required and recommended changes. For any questions, call (727) 789-0100.
Quantity in Commerce 220
Distribution Worldwide Distribution - USA (nationwide) and the country of: Canada.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.