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Terminated

Hospital Information System Results Reporting Interface Versions 4.0.2.38.1, 4.0.2.39.2, 4.02.40.1, and 4.0.2.41.1. SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760. Manufacture Dates: 4.0.2.38.1 06/15/07 4.02.39.2 06/29/07, 4.02.40.1 07/19/07, 4.02.41.1 08/20/07. The Result Reporting Interface is a highly versatile interface designed to electronically convey clinical laboratory orders and results for the SCC applications to other recipient information systems.

FDA Recall Z-0069-2011 · Posted 2010-10-15

Recalling FirmSCC Soft Computer
Recall StatusTerminated
Product CodeLNX
Date Initiated2007-10-05
Date Terminated2010-10-19
Product Quantity35

Reason for Recall

SCC Soft Computer, Clearwater, FL issued a Correction for Hospital Information System Results Reporting Interface Versions 4.0.2.38.1, 4.0.2.39.2, 4.0.2.40.1, and 4.0.2.41.1 on 10/05/2007. A software anomaly in the result reporting interface caused result comments entered after an empty line not to be sent to the HIS system. This included interpretative comments, results, and normal range c

Firm Action

SCC Soft Computer sent a RISK-TO-HEALTH NOTIFICATION TASK VERBIAGE dated October 5, 2007, through their Task Management System to all affected clients on October 17, 2007. The notice identified the product, the problem and the action clients should take to correct the problem. Clients were to acknowledge receipt of the task notice and to identify if the Workflow or functionality is not used and if they Agree to use alternative working solutions. Each client was asked to grant permission to load the required software to correct the issue. For any questions regarding this recall call (727) 789-0100.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution - USA, including AL, CO, FL, GA, IN, KS, KY, MA, MO, NC, NH, NJ, NY, OH, PA, TN, and WA and the 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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