Class 2 Device Recall SoftPath

• Date Initiated by Firm: October 27, 2004
• Date Posted: July 27, 2006
• Recall Status: Terminated on July 19, 2010
• Recall Number: Z-1243-06
• Recall Event ID: 35377
• Product Classification: diagnostic test result software - Product Code JQP
• Product: Product is SoftPath ASCII Software Releases 2.3.0 and 4.3.7. The software is used in pathology labs for administrative and clinicial documentation and data processing.
• Code Information: Releases 2.3.0 and 4.3.7.
• FEI Number: 1000307651
• Recalling Firm/ Manufacturer: SCC Soft Computer; 34350 US Highway 19 N; Palm Harbor FL 34684-2149
• Manufacturer Reason for Recall: Text from one case is overwriting another. This could cause an incorrect diagnostic report to be sent to a clinician/surgeon.
• FDA Determined Cause: Other
• Action: Consignees were notified and the products were corrected by the firm.
• Quantity in Commerce: 4
• Distribution: Product was distributed to 4 clients, two in the United States and two in 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.