FDA Device recall Z-2276-2021
Alinity s System REF 06P16-01
- FDA Device
- Class II
- ongoing
- Published 2021-08-18
On 2021-08-18 the FDA classified a Class II recall of Alinity s System REF 06P16-01 by Abbott Laboratories, citing A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2276-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-07-12 |
| Published | 2021-08-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Abbott Laboratories |
| Distribution | US |
Product
Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and reference laboratories.
Reason
A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators.
Identifiers
| code_info | Model Number: LN 06P16-01 Serial numbers AS1001 through AS1330 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2276-2021%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.