FDA recall Z-2098-2021
Soft Computer Consultants, Inc. · Class II · device
Product
SoftCytogenetics
Reason for recall
Software is given wrong results going out to HIS on test that had reruns.
Distribution
US Nationwide Distribution in the states of CA, FL, MN and NJ.
Key facts
- Status
- Terminated
- Initiation date
- 2021-03-31
- Report date
- 2021-07-28
- Termination date
- 2023-02-14
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Clearwater, FL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2098-2021