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U.S. Department of Health and Human Services

Class 2 Device Recall SoftLab/Mic ASCII Addon

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 Class 2 Device Recall SoftLab/Mic ASCII Addonsee related information
Date Initiated by FirmFebruary 16, 2010
Date PostedNovember 10, 2010
Recall Status1 Terminated 3 on July 17, 2012
Recall NumberZ-0344-2011
Recall Event ID 56863
Product Classification Calculator/Data Processing Module for Clinical Use - Product Code JQP
ProductSoftLab/Mic ASCII Add-on Versions 4.0.1.14, 4.0.1.15, and 4.0.1.16. SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. Version 4.0.1.14 Manufactured & Distributed 12/29/2006. Version 4.0.1.15 Manufactured & Distributed 05/02/2007. Version 4.0.1.16 Manufactured & Distributed 08/22/2008. Used in a medical research or clinical laboratory setting by knowledgeable, trained and experienced personnel.
Code Information Versions 4.0.1.14, 4.0.1.15, and 4.0.1.16.
Recalling Firm/
Manufacturer		 SCC Soft Computer
5400 Tech Data Drive
Clearwater FL 33760
For Additional Information Contact
727-789-0100
Manufacturer Reason
for Recall		When a test is being verified, the wrong (expired) ranges may be associated to that test result, causing an incorrect flag to be posted for that test result.
FDA Determined
Cause 2		Software design
ActionClients were notified via the proprietary communication software on 02/16/2010. The Notification Verbiage identified the affected product and informed clients of the potential hazard, root cause, corrective action, and requested action. Clients were instructed to acknowledge receipt of the notification. If the client wishes to receive the correction, they should document a request to load the software.
Quantity in Commerce31
DistributionNationwide Distribution - US and Puerto Rico.
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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