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U.S. Department of Health and Human Services

Class 2 Device Recall SoftLab with SA HIS versions 4.0.7.04.0.7.1

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 Class 2 Device Recall SoftLab with SA HIS versions 4.0.7.04.0.7.1see related information
Date Initiated by FirmMay 20, 2014
Date PostedFebruary 02, 2015
Recall Status1 Terminated 3 on May 16, 2016
Recall NumberZ-1038-2015
Recall Event ID 70021
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
ProductSoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory information system to be used in a medical research or clinical laboratory.
Code Information 4.0.7.0: released 12/13/13 - present 4.0.7.1: released 02/28/14 - present
Recalling Firm/
Manufacturer		 SCC Soft Computer
5400 Tech Data Drive
Clearwater FL 33760
For Additional Information ContactJoseph McBride
727-789-0100
Manufacturer Reason
for Recall		The interface fails to send abnormal flags for Reference Lab test results.
FDA Determined
Cause 2		Device Design
ActionThe firm sent out 2 CORRECTION COMMUNICATIONS informing consignees of functionality in release of 4.0.7 HIS Add-on interfaces which SCC has designated to be a potential patient Risk-to-Health issue. Further the corrective action indicated HIS releases 4.0.7.2 and higher will be corrected. Hot Fixes have been developed for HIS Add-on patches 4.0.7.0 and 4.0.7.1. Lastly the communication requests that the user "please acknowledge receipt of this task and grant permission to load the mandatory hot fix(es). Thank you."
Quantity in Commerce48
DistributionDistributed US (nationwide) in the states of OH, GA, NJ, WI, FL, NH, IL, NY, IN, CA, AL, VA, MO, MI, KY, MA, PA, CO, ME, TN, WA, MN, SD, LA, NC, and NV and the country of Canada.
Total Product Life CycleTPLC 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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