Company: SCC Soft Computer
Date of Enforcement Report 11/24/2010
Class ll:
PRODUCT
SoftMic Versions 4.0.4.7, 4.5.1.3. Version 4.0.4.7 Manufactured 02/03/2010. Version 4.5.1.3 Manufactured 03/18/2010. Recall # Z-0088-2011
REASON
Softmic system may delay or omit reporting of clinically significant results including organisms and drug sensitivities. Incomplete culture results may appear complete. SCC Soft Computer is issuing a Correction for SoftMic Versions 4.0.4.7-4.5.1.3 software due to this potential hazard.
RECALLING FIRM/MANUFACTURER
SCC Soft Computer, Clearwater, FL, by letters on July 19, 2010. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
35 units
DISTRIBUTION
Nationwide and Canada
