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
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Reason for Recall
Firm Action
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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