Z-0069-2011

Hospital Information System Results Reporting Interface Versions 4.0.2.38.1, 4.0.2.39.2, 4.02.40.1, and...

Name: Z-0069-2011 Hospital Information System Results Reporting Interface Versions 4.0.2.38.1, 4.0.2.39.2, 4.02.40.1, and...
Creator: SCC Soft Computer
Published: 2007-10-05
License: https://open.fda.gov/license/

SCC Soft Computer / initiated 2007-10-05 / Terminated / root cause: software

FDA source

SCC Soft Computer began a recall of 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... on 2007-10-05. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0069-2011
Status: Terminated
Initiated: 2007-10-05
Posted: 2010-10-15
Terminated: 2010-10-19
Recalling firm: SCC Soft Computer
Product: 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.
Product code: LNX
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
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 35
Distribution: 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
Product codes and lots: Versions 4.0.2.38.1, 4.0.2.39.2, 4.02.40.1, and 4.0.2.41.1.

Product code LNX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)