FDA Device recall Z-0543-2020
Alinity ci Level Sensor, Bulk Solution
- FDA Device
- Class II
- ongoing
- Published 2019-12-04
On 2019-12-04 the FDA classified a Class II recall of Alinity ci Level Sensor, Bulk Solution by Abbott And Kg, citing potential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The development of environmental stress on the bulk solution level sensor can cause cracks.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0543-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-09-16 |
| Published | 2019-12-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Abbott And Kg |
| Distribution | US |
Product
Alinity ci Level Sensor, Bulk Solution
Reason
Potential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The development of environmental stress on the bulk solution level sensor can cause cracks.
Identifiers
| code_info | List Number 04S68-02, All Serial Numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0543-2020%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.