FDA Enforcement
Class II
Terminated
SoftCytogenetics
Recall: Z-2098-2021
·
Reported July 28, 2021
Enforcement
- Recall Number
- Z-2098-2021
- Event ID
- 88105
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Soft Computer Consultants, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 28, 2021
- Initiation Date
- March 31, 2021
- Classification Date
- July 19, 2021
- Termination Date
- February 14, 2023
- Address
- 5400 Tech Data Dr, N/A, Clearwater, FL, 33760-3116, United States
Description
SoftCytogenetics
Reason
Software is given wrong results going out to HIS on test that had reruns.
Code Info
Versions: 4.1.11.20, 4.1.12.11 and 4.1.15.6
Distribution
US Nationwide Distribution in the states of CA, FL, MN and NJ.
Quantity
5