FDA Device recall Z-1580-2020
LN 3R70-01
- FDA Device
- Class II
- terminated
- Published 2020-04-01
On 2020-04-01 the FDA classified a Class II recall of LN 3R70-01 by Abbott And Kg, citing abbott has identified potential performance issues for the Alinity ci -series Software version 2.6.2 and earlier.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1580-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-24 |
| Published | 2020-04-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Abbott And Kg |
| Distribution | US |
Product
LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i (LN 03R65-01) processing module and the Alinity c (LN 03R67-01) processing module.
Reason
Abbott has identified potential performance issues for the Alinity ci -series Software version 2.6.2 and earlier.
Identifiers
| code_info | LN 3R70-01; software version 2.6.2 and earlier. |
|---|
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-1580-2020%22
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