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U.S. Department of Health and Human Services

Class 2 Device Recall Soft Lab

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  Class 2 Device Recall Soft Lab see related information
Date Initiated by Firm October 17, 2011
Date Posted August 03, 2012
Recall Status1 Terminated 3 on September 03, 2014
Recall Number Z-2143-2012
Recall Event ID 62023
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product SoftLab with SA INST versions:,,, and

Product UsageSoftLab 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 SA INST versions:,,, and
Recalling Firm/
SCC Soft Computer
5400 Tech Data Drive
Clearwater FL 33760
For Additional Information Contact Kathryn Branca
Manufacturer Reason
for Recall
On 10/17/2011 SCC Soft Computer, Clearwater, FL initiated a correction on SoftLab with SA INST versions:,,, and A client reported an issue which caused two different sets of results from the Sysmex series of Hematology instruments to display under the same order on the instrument menu.
FDA Determined
Cause 2
Software design
Action SCC Soft Computer's proprietary Task Management System sent a correction communication letter to all consignees with affected software. The letter identified the affected product, problem and corrective actions to be taken. The letter also recommended alternative working solution if the corrective actions cannot be used. Consignees with affected software are scheduling receipt of the software correction. For questions call 727-789-0100.
Quantity in Commerce 88
Distribution US Nationwide Distribution
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.