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U.S. Department of Health and Human Services

Class 2 Device Recall SoftPath

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  Class 2 Device Recall SoftPath see related information
Date Initiated by Firm January 09, 2001
Date Posted July 26, 2006
Recall Status1 Terminated 3 on July 19, 2010
Recall Number Z-1252-06
Recall Event ID 35375
Product Classification pathology lab software - Product Code JQP
Product SoftPath ASCII Software, used in pathology labs to track and report specimens and diagnostic results. Releases 1.2, 2.1, and 2.3
Code Information Releases 1.2, 2.1, and 2.3
Recalling Firm/
Manufacturer
SCC Soft Computer
34350 US Highway 19 N
Palm Harbor FL 34684-2149
Manufacturer Reason
for Recall
The client had made a decision to use the SoftPath Module in a nonstandard manner. Under specific circumstances, incorrect text may appear on a patient report.
FDA Determined
Cause 2
Other
Action The firm issued a software correction letter to its consignees 1/9/2001, advising them of the problem and supplied them with a software patch ICC number 3618 also referred to as release 3.0. The firm advised its clients that the installation of this software to their system was mandatory.
Quantity in Commerce 171
Distribution 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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