Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

SoftLab GUI Version 4.0.1.0 - 4.0.1.16, 4.0.2.0 - 4.0.2.10, 4.0.3.0 - 4.0.3.13, and 4.0.4.0 - 4.0.4.5. SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. Manufacture/Distribution Dates: 4.0.1.0 - 08/06/04, 4.0.1.4 - 10/18/04, 4.0.1.5 - 01/18/04, 4.0.1.6 - 12/15/04, 4.0.1.7 - 01/10/05, 4.0.1.8 - 03/29/05, 4.0.1.9 - 05/06/05, 4.0.1.13 - 01/25/06, 4.0.1.14 - 03/26/07 4.0.1.15 - 05/02/07, 4.0.1.16 - 08/22/08, 4.0.2.0 - 04/08/05, 4.0.2.1 - 08/13/08, 4.0.2.2 - 06/06/05, 4.0.2.3 - 09/19/05, 4.0.2.4 - 09/19/05, 4.0.2.5 - 09/19/05, 4.0.2.7 - 02/13/06, 4.0.2.8 - 12/12/06, 4.0.2.9 - 02/20/08, 04.2.10 - 08/13/08, 4.0.3.2 - 05/17/06, 4.0.3.3 - 09/18/06, 4.0.3.4 - 09/27/06, 4.0.3.5 - 11/29/06, 4.0.3.6 - 06/22/07, 4.0.3.7 - 03/28/07, 4.0.3.8 - 06/22/07, 4.0.3.9 - 08/03/07, 4.0.3.10 - 08/24/07, 4.0.3.11 - 09/24/07, 4.0.3.12 - 03/07/08, 4.0.3.13 - 06/13/08, 4.0.4.2 - 02/22/08, 4.0.4.3 - 05/22/08, 4.0.4.4 - 07/28/08, 4.0.4.5 - 05/04/09. Intends to provide clients with an interface that links all clinical laboratory departments throughout the enterprise.

FDA Recall Z-0365-2011 · Posted 2010-11-16

Recalling FirmSCC Soft Computer
Recall StatusTerminated
Product CodeJQP
Date Initiated2009-04-01
Date Terminated2013-08-07
Product Quantity49

Reason for Recall

Clients using Patient Maintenance to perform Moves of Stays may send the wrong billing number during an ADT update to SoftWeb, SoftPath or SoftMedia. The wrong billing number can come from a different patient in Order Entry. Only Moves of Stays are affected.

Firm Action

Clients were notified via the proprietary communication software on 06/01/2009. This is a MANDATORY CORRECTION. The Risk-To-Health Notification Task gives the background on the issue, the potential hazard, root cause, corrective action, alternative working solution, and requested action. Clients were instructed to acknowledge receipt of the notification. If the client wishes to receive the correction, they should document a request to load the software.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

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

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