FDA Device recall Z-0044-2020
AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determi…
- FDA Device
- Class II
- terminated
- Published 2019-10-16
On 2019-10-16 the FDA classified a Class II recall of AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determi… by Roche Diagnostics Operations, citing assayTips part of the AssayTip/AssayCup Tray Tips used on the cobas e 801 module- may have an Abnormal Internal Structure and lead to Incorrect patient results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0044-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-08-13 |
| Published | 2019-10-16 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Roche Diagnostics Operations |
| Distribution | US |
Product
AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determination of analytes in human body fluids) Catalog Number: 5694302001
Reason
AssayTips part of the AssayTip/AssayCup Tray Tips used on the cobas e 801 module- may have an Abnormal Internal Structure and lead to Incorrect patient results
Identifiers
| code_info | Lot Numbers: 18636170 18665170 18667170 18668170 18215274 18245274 18250274 18251274 18252274 18253274 18265274 18271274 19209274 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0044-2020%22
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