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U.S. Department of Health and Human Services

Class 2 Device Recall SCC SA HIS version when used with SoftMic version

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  Class 2 Device Recall SCC SA HIS version when used with SoftMic version see related information
Date Initiated by Firm January 29, 2014
Date Posted May 09, 2014
Recall Status1 Terminated 3 on November 03, 2014
Recall Number Z-1573-2014
Recall Event ID 67970
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product SCC SA HIS version when used with SoftMic version

SoftMic is a laboratory information system to be used in medical results, 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 SA HIS version
Recalling Firm/
SCC Soft Computer
5400 Tech Data Drive
Clearwater FL 33760
For Additional Information Contact Joseph McBride
727-789-0100 Ext. 4678
Manufacturer Reason
for Recall
When an isolate is resulted without a SNOMED code, isolate information in the downstream system may be incomplete or missing. As a result, there is the potential for the delay or omission of patient treatment updates.
FDA Determined
Cause 2
Software design
Action On 2/10/2014 SCC Soft Computer used a proprietary task management system to send a Correction Communication to the consignee with the affected software. The letter identifies the product, problem and corrective actions.
Quantity in Commerce 1
Distribution Distributed in IL.
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.