Device product
SoftCytogenetics
Z-2098-2021
Product summary
- Event
- Event 88105
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5
- Official record key
device-enforcement:Z-2098-2021
Official wording
Reason: Software is given wrong results going out to HIS on test that had reruns.
Code information: Versions: 4.1.11.20, 4.1.12.11 and 4.1.15.6
Distribution pattern: US Nationwide Distribution in the states of CA, FL, MN and NJ.
Derived failure modes
-
Unknown
Software is given wrong results going out to HIS on test that had reruns.