FDA-Device2017-08-09Class II

SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained,

Soft Computer Consultants, Inc.
Hazard

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.

Sold states
US Distribution to states of: CA, IL, LA, MA, MD, MI, MN, NJ, NY, PA, and TX.
Affected count
18 units
Manufactured in
5400 Tech Data Dr, N/A, Clearwater, FL, United States
Products
SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained,

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2865-2017

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