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Terminated

Soft Query Results Reporting Versions 2.2.0.6.3 and 2.2.0.7.1. SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760. Soft Query Results Reporting version 2.2.0.6.3 was released for General Availability on 09/11/03. Soft Query Results Reporting version 2.2.0.7.1 was released for General Availability on 01/08/04.

FDA Recall Z-0074-2011 · Posted 2010-10-18

Recalling FirmSCC Soft Computer
Recall StatusTerminated
Product CodeLNX
Date Initiated2004-11-30
Date Terminated2010-10-19
Product Quantity5

Reason for Recall

Soft Query Results Reporting Versions 2.2.0.6.3 and 2.2.0.7.1 HIS may display incorrect collection data for a procedure or test result. Clients using HBO Star RR interface to query for results on a canceled test may see the previous occurrence of the test with the current date and time displayed as the collection date and time instead of the correct collection date and time sent by the SCC interf

Firm Action

Client Notification Task Verbiage was sent through the Task Management System on December 3, 2003, identifying the software issue, the clinical impact, and corrective action. Customers were informed that the HIS may display incorrect collection data. Customers received the SQRR Service Pack with revised software, which will will not produce inaccurate information if there are no verified results. Customers were to acknowledge receipt of the task notification and indicate whether they would like the corrected software. SCC Soft Computer proprietary Task Management System is used to manage client communication. Clients use this system to request services, receive and provide software updates for any issue. Customers can contact SCC Soft Computer at 727-789-0100.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution: including states of GA, LA, and NH.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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