SoftLab Software Lab information system Cl II

Company:Soft Computer Consultants, Inc.
Date of Enforcement Report 8/9/2017
ClasslI:

PRODUCT

SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained,
Recall Number Z-2865-2017

REASON
Display of lab results based on incorrect LOINC code/test descriptions for tests that were performed at a reference lab, saved incorrectly, and sent to systems that display the EMR.

RECALLING FIRM/MANUFACTURER
Soft Computer Consultants, Inc., clearwater, FL on 5/31/2017. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
18 units

DISTRIBUTION
US Distribution to states of: CA, IL, LA, MA, MD, MI, MN, NJ, NY, PA, and TX.

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Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)!  Email training@softwarecpr.com
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QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
For info on this course, email training@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.