Cl ll SoftLab GUI

Company: SCC Soft Computer..
Date of Enforcement Report 12/22/2010
Class ll:

PRODUCT
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. 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. Recall # Z-0365-2011

REASON
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.

RECALLING FIRM/MANUFACTURER
SCC Soft Computer, Clearwater, Fl, via the proprietary communication software on June 1, 2009. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
40 units

DISTRIBUTION
Nationwide

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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