FDA Device recall Z-2098-2021
SoftCytogenetics
- FDA Device
- Class II
- terminated
- Published 2021-07-28
On 2021-07-28 the FDA classified a Class II recall of SoftCytogenetics by Soft Computer Consultants, citing software is given wrong results going out to HIS on test that had reruns.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2098-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-31 |
| Published | 2021-07-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Soft Computer Consultants |
| Distribution | US |
Product
SoftCytogenetics
Reason
Software is given wrong results going out to HIS on test that had reruns.
Identifiers
| code_info | Versions: 4.1.11.20, 4.1.12.11 and 4.1.15.6 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2098-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.