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U.S. Department of Health and Human Services

Class 2 Device Recall SoftMic GUI versions: 4.0.3.04.0.3.15, 4.0.4.14.0.4.7.

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  Class 2 Device Recall SoftMic GUI versions: 4.0.3.04.0.3.15, 4.0.4.14.0.4.7. see related information
Date Initiated by Firm August 25, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on October 03, 2014
Recall Number Z-0466-2012
Recall Event ID 60459
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product SoftMic GUI versions: 4.0.3.0-4.0.3.15, 4.0.4.1-4.0.4.7.

SoftMic is a laboratory information system to be used in medical research, clinical, and public health laboratories by knowledgeable, trained, and experienced personnel. SoftMic enables the user to handle data processing and laboratory activities for microbiology and serology testing, for the purpose of storing, managing, querying, and reporting laboratory data.
Code Information SoftMic GUI versions: 4.0.3.0-4.0.3.15, 4.0.4.1-4.0.4.7.
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 08/25/2011, SCC Soft Computer initiated a correction on the following SoftMic GUI versions: 4.0.3.0-4.0.3.15, 4.0.4.1-4.0.4.7. For clients using SoftMic Result Entry, when a certain series of keystrokes on the test grid are performed while entering results and statusing a test, the test status may not be maintained upon saving. The status may be removed or copied from another test on the order
FDA Determined
Cause 2		 Software design
Action SCC Soft Computer initiated a Field Correction dated August 25, 2011. to all affected customers. Customers with the affected software have been notified and are scheduling receipt of the hot fix.. Further questions call (727) 789-0100.
Quantity in Commerce 144
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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