Recall Z-2865-2017— Soft Computer Consultants, Inc.

Name: FDA recall Z-2865-2017
Creator: U.S. Food and Drug Administration
Published: 2017-05-31

Class II · Terminated

Class II FDA medical device recall by Soft Computer Consultants, Inc., initiated 2017-05-31, terminated 2020-08-04. FDA's recall record names no specific 510(k) clearance for this event. Product: SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained,. 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: Soft Computer Consultants, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-05-31
Terminated: 2020-08-04
Firm location: Clearwater, FL, United States

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.