SoftPath GUI Release Software Versions 3.17 and 4.1. Used in pathology laboratory for receiving accessing specimen reports, billing and management reports for surgical, GYN, NON-GYN and Autopsy cases.
This recall has been terminated (originally issued September 22, 2008).
- Company
- Scc Soft Computer
- Recall Initiated
- February 23, 2006
- Posted
- September 22, 2008
- Terminated
- November 20, 2008
- Recall Number
- Z-2329-2008
- Quantity
- 335
- Firm Location
- Clearwater, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Loss of text misrepresented individual tissue diagnosis on the final diagnosis print out from the HIS system software. The specimen heading "J" was removed and the diagnosis appeared under the specimen heading "I" as a result the specimen with the heading "I" had two diagnosis.
Distribution
Worldwide Distribution including USA and the country of Canada.
Lot / Code Info
Versions 3.17 and 4.1
Root Cause
Other
Action Taken
Software corrections were sent as of 10/30/2003 for clients to upgrade to, the correction software patch is in versions 3.17.5.16, 3.17.6.10, 3.17.7.3 and 4.1.1.0. The firm did not inform the non-affected consignees of the failure because the firm concluded that the associated risk was low.