Medical device recalls Moderate risk

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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