SoftPath GUI Versions: 4.3.0.10, 4.3.0.11, and 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.
This recall has been terminated (originally issued December 2, 2011).
- Company
- Scc Soft Computer
- Recall Initiated
- June 13, 2011
- Posted
- December 2, 2011
- Terminated
- May 31, 2012
- Recall Number
- Z-0355-2012
- Quantity
- 14
- Firm Location
- Clearwater, FL
- Official Source
- View on FDA website ↗
Reason for Recall
On 06/13/2011, SCC Soft Computer initiated a correction on the following SoftPath GUI Versions: 4.3.0.10, 4.3.0.11, and 4.3.0.12. A client reported when they verified the contents of the fax reports, they found one of the specimen diagnoses to be missing. Parts A through D were present as well as Part F, however, Part E diagnosis was missing for one of the patient reports. All affected clients wer
Distribution
Class II Recall - Worldwide Distribution -- USA (nationwide) and the country of Canada.
Lot / Code Info
SoftPath GUI Versions: 4.3.0.10, 4.3.0.11, and 4.3.0.12.
Root Cause
Device Design
Action Taken
SCC Soft Computer initiated a Field Correction on June 13, 2011. All customers with affected software have been notified of this issue. SCC recommends until the corrected patch is loaded to temporarily use one of the following alternative working solutions: 1. Use MS Word Editor functionality within SoftPath application for creating patient reports. In order to ensure Text Control editor is not inadvertently activated, the templates for Text Control editor will be deleted and reinstalled at the clients request by their SCC representative after receipt of the correction. 2. In Report Template set-up, the bottom margin should be made slightly larger than the size of the footer plus its distance from the bottom page border. For further explanation, please consult your SCC representative for further details, or call (727) 789-0100.