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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