RecallDepth

SoftWeb version 4.0.4.10.1. SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760. Manufacture Date: 05/16/2006.

This recall has been terminated (originally issued October 20, 2010).

Company
Scc Soft Computer
Recall Initiated
June 8, 2006
Posted
October 20, 2010
Terminated
November 3, 2010
Recall Number
Z-0099-2011
Quantity
1
Firm Location
Clearwater, FL
Official Source
View on FDA website ↗

Reason for Recall

If a case number is re-used in SoftWeb with SoftPath, the SoftPath case is linked to the original MRN in SoftWeb. This causes SoftPath cases being linked to the wrong patient in SoftWeb. Incorrect results on the patient with original MRN and no results on the patient with the second MRN (and the reused case number) are displayed in SoftWeb Results Query. SCC Soft Computer issued a Correction for

Distribution

Nationwide Distribution: 1 hospital in Alaska.

Lot / Code Info

version 4.0.4.10.1.

Root Cause

Software design

Action Taken

SCC Soft Computer issued a Risk-to-Health notification with Client Notification Verbiage to the affected client using SCC Soft Computer's proprietary Task Management System on June 8, 2006. SCC recommended SoftPath/SoftWeb users NOT re-use SoftPath case numbers when cases are cancelled. The generic option setting "Specimen Registration - Standard Settings - Minimum Time to Reactivate Case Number" should be set to "0" so the user is not prompted to reuse the same case number. Client was asked to acknowledge receipt of the task and grant permission to load the required software correction.

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