Z-2098-2021 Class II Terminated
FDA device recall Z-2098-2021 was initiated by Soft Computer Consultants, Inc. on March 31, 2021 and is designated Class II. Reason for recall: Software is given wrong results going out to HIS on test that had reruns. The recall status is terminated (terminated February 14, 2023). Affected quantity: 5.
Recall Details
- Product Type
- Devices
- Report Date
- July 28, 2021
- Initiation Date
- March 31, 2021
- Termination Date
- February 14, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5
Product Description
SoftCytogenetics
Reason for Recall
Software is given wrong results going out to HIS on test that had reruns.
Distribution Pattern
US Nationwide Distribution in the states of CA, FL, MN and NJ.
Code Information
Versions: 4.1.11.20, 4.1.12.11 and 4.1.15.6