SoftPath GUI versions: 4.2.3.3-4.2.3.6 and 4.3.0.5-4.3.0.12. SoftPath is a laboratory information system to be used in a clinical laboratory by knowledgeable, trained, and experienced personnel. SoftPath enables the user to document steps in the receiving and processing of surgical, gynecological, medical cytological, and autopsy case specimens within the Pathology labs, for the purpose of generating Pathology reports for requesting physicians and label creation for identification of specimen/case material.
FDA Recall Z-0363-2012 · Posted 2011-12-02
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Recalling FirmSCC Soft Computer
Recall StatusTerminated
Product CodeJQP
Date Initiated2011-07-20
Date Terminated2013-05-21
Product Quantity97
Reason for Recall
On 07/20/2011 SCC Soft Computer, Clearwater, FL, initiated a correction on the following SoftPath GUI versions: 4.2.3.3-4.2.3.6 and 4.3.0.5-4.3.0.12. A client reported that the HPV results on a patient report were incorrect. The HPV results were from the previous order on the patient and not the current order. All affected clients were notified about the issue on 07/20/2011.
Firm Action
SCC Soft Computer sent a "CORRECTION COMMUNICATION" dated July 20, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. SCC personnel will review the customized Lab Results AP macro and/or the Micro Results AP macro on customer systems and will either discuss with them the irregularities requiring change or reconfigure macros as necessary.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution-USA (nationwide) and the country of Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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