FDA-Device2021-07-28Class II
SoftCytogenetics
Soft Computer Consultants, Inc.
Hazard
Software is given wrong results going out to HIS on test that had reruns.
Sold states
US Nationwide Distribution in the states of CA, FL, MN and NJ.
Affected count
5
Manufactured in
5400 Tech Data Dr, N/A, Clearwater, FL, United States
Products
SoftCytogenetics
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2098-2021Don't want to check this manually?
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