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