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U.S. Department of Health and Human Services

Class 3 Device Recall SoftLab

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  Class 3 Device Recall SoftLab see related information
Date Initiated by Firm July 26, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on May 21, 2013
Recall Number Z-0444-2012
Recall Event ID 60455
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product SoftLab used with SA INST 4.0.2.0 to 4.0.2.51, 4.0.3.0 to 4.0.3.13, 4.5.0.0 to 4.5.0.9, 4.5.2.0 to 4.5.2.8 and SA INST 3.1.3.0 to 3.1.3.29, 3.1.6.0 to 3.1.6.17, 4.0.0.0, 4.0.1.0 to 4.0.1.32.

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 used with SA INST 4.0.2.0 to 4.0.2.51, 4.0.3.0 to 4.0.3.13, 4.5.0.0 to 4.5.0.9, 4.5.2.0 to 4.5.2.8 and SA INST 3.1.3.0 to 3.1.3.29, 3.1.6.0 to 3.1.6.17, 4.0.0.0, 4.0.1.0 to 4.0.1.32.
Recalling Firm/
Manufacturer		 SCC Soft Computer
5400 Tech Data Drive
Clearwater FL 33760
For Additional Information Contact Kathryn Branca
727-789-0100
Manufacturer Reason
for Recall		 SCC Soft Computer, Clearwater, FL, initiated a correction for the SoftLab used with SA INST. A test performed on the Roche Cobas Integra series of instruments when used with the GenInst/Dispatch listening program could cause incorrect flagging for a test result posted to the lab database.
FDA Determined
Cause 2		 Software design
Action The firm, SCC Soft Computer, sent a "Correction Communication" letter on July 26, 2011 to customers/consignees. The letter describes the product problem and actions to be taken. The firm will correct the software to recognize and support all known formats of the resulting date and time sent by an instrument. The software is available via a recommended patch or hot fix to the client's current release. The customers were asked to acknowledge receipt of the task and grant permission for SCC to correct the affected configuration files. If you have any questions, call (727) 789-0100.
Quantity in Commerce 265
Distribution Worldwide Distribution - USA (Nationwide) and 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.
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