Nov

2010

Cl ll SoftMic

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

About the author

Amy Sellers

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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Cl ll SoftMic

Amy Sellers

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