FDA Device recall Z-2701-2020
Alinity ci series System Control Module (SCM)
- FDA Device
- Class II
- terminated
- Published 2020-08-05
On 2020-08-05 the FDA classified a Class II recall of Alinity ci series System Control Module (SCM) by Abbott And Kg, citing quality Control results were not properly evaluated for QC failures.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2701-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-06-19 |
| Published | 2020-08-05 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Abbott And Kg |
| Distribution | US |
Product
Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series software versions, 3.1.1 and below
Reason
Quality Control results were not properly evaluated for QC failures.
Identifiers
| code_info | All serial numbers of System Control Module |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2701-2020%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.