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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CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

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