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Terminated

SoftPath GUI versions: 3.17.5 to 3.17.9, 4.2.1 to 4.2.3, and 4.3.0 to 4.3.0.4. 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-0209-2012 · Posted 2011-11-17

Recalling FirmSCC Soft Computer
Recall StatusTerminated
Product CodeJQP
Date Initiated2011-07-13
Date Terminated2012-07-17
Product Quantity142

Reason for Recall

Soft Computer, Clearwater, FL, initiated a correction on the following SoftPath GUI versions: 3.17.5 to 3.17.9, 4.2.1 to 4.2.3, and 4.3.0 to 4.3.0.4. SoftPath architecture does not correctly handle AP macros and data fields inside report sections that are stored in the database. Improper information can be displayed in all places where the diagnosis from the database is read and displayed.

Firm Action

The firm, SCC Soft Computer, sent a "CORRECTION COMMUNICATION" notice on July 13, 2011 to its customers. The notice describes the product, problem and actions to be taken. The customers were instructed to restrict security access to the template set-up files and to acknowledge receipt of the notice; grant SCC personnel permission to check their report templates and correct any that are affected; indicate if they wish to schedule the utility to be run and if they would like to have the SoftWeb parameter PathPDFLinkOnly set to "Y". SCC will review the templates on the customers systems; discuss any irregularities requiring change and move or remove AP macros and data elements as needed. If you have any questions, contact the Director of Quality Management at (727)789-0100.

Root Cause

Software design

Distribution Pattern

Worldwide distribution: USA (nationwide) including states of: AR, AL, AZ, CA, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MN, NH, NJ, NY, OH, OK, PA, SD, TX, VA, WA, WI, WV including Puerto Rico; 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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