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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