FDA Device recall Z-0131-2015
Lipase Reagent, 7D80
- FDA Device
- Class II
- terminated
- Published 2014-11-05
On 2014-11-05 the FDA classified a Class II recall of Lipase Reagent, 7D80 by Abbott Laboratories, citing package inserts have incorrect SmartWash parameters for Triglyceride.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0131-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-07 |
| Published | 2014-11-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Abbott Laboratories |
| Distribution | US |
Product
Lipase Reagent, 7D80. Used to measure lipase in human serum on the Architect system.
Reason
Package inserts have incorrect SmartWash parameters for Triglyceride.
Identifiers
| code_info | lots 43827UQ12, 43819UQ03, 44449UQ05, 44127UQ06, 44334UQ07, 43994UQ07, 44596UQ08, 44775UQ09, and 44930UQ11. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0131-2015%22
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