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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 August 08, 2011
Date Posted November 21, 2011
Recall Status1 Terminated 3 on November 22, 2013
Recall Number Z-0261-2012
Recall Event ID 60405
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product Software: SA BASE 3.1.4.x, 3.1.6.x and SA LabMic 4.0.0.x, 4.0.1.x, 4.0.2.x, 4.0.3.x, 4.0.4.x.

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 Versions: SA BASE 3.1.4.x, 3.1.6.x and SA LabMic 4.0.0.x, 4.0.1.x, 4.0.2.x, 4.0.3.x, 4.0.4.x.
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		 On 08/08/2011 SCC Soft Computer, Clearwater, FL initiated a correction on following SoftLab used with: SA BASE 3.1.4.x, 3.1.6.x and SA LabMic 4.0.0.x, 4.0.1.x, 4.0.2.x, 4.0.3.x, 4.0.4.x. A client reported a flagging error where the result was flagged as critical in the Instrument Menu but the printed report did not show the corresponding flag. All affected clients were notified of the issue on 0
FDA Determined
Cause 2		 Software design
Action SCC Soft Computer notified all affected customers on August 8, 2011, of the recall via the SCC Soft Computer proprietary Task management system to manage client communication. Clients use this tool to log in requests for services and receive and provide updates to any issue. Each client user has a unique password and every action is date and time-stamped. Each Task has a unique identifier and a full audit trail. SCC recommended to the customer until Live on the correction avoid making edits in the instrument menu. For further questions please call (727) 789-0100.
Quantity in Commerce 255
Distribution Worldwide Distribution - USA ( nationwide) and 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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