Medical device recalls Moderate risk

Soft Computer Consultants, Inc. recalls SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable…

Recall date
May 31, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2865-2017
FDA classification
Class II
Brand / firm
Soft Computer Consultants, Inc.
Sold / distributed
US Distribution to states of: CA, IL, LA, MA, MD, MI, MN, NJ, NY, PA, and TX.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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