Soft Computer Consultants, Inc. recalls SoftCytogenetics
- Recall date
- March 31, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2098-2021
- FDA classification
- Class II
- Brand / firm
- Soft Computer Consultants, Inc.
- Sold / distributed
- US Nationwide Distribution in the states of CA, FL, MN and NJ.
Why it was recalled
Software is given wrong results going out to HIS on test that had reruns.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
SoftCytogenetics
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