AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part… — Class II medical device recall Z-0044-2020
Terminated recall by Roche Diagnostics Operations, Inc., reported 2019-10-16, distributed nationwide. AssayTips part of the AssayTip/AssayCup Tray Tips used on the cobas e 801 module- may have an Abnormal Interna
| Recall number | Z-0044-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Operations, Inc., Indianapolis, IN, United States |
| Recall initiated | 2019-08-13 |
| Classified | 2019-10-04 |
| Reported by FDA | 2019-10-16 |
| Terminated | 2022-06-30 |
| Distributed | Nationwide (US) |
| Quantity | 935 units |
| Lot numbers | 18215274, 18245274, 18250274, 18251274, 18252274, 18253274, 18265274, 18271274, 18636170, 18665170, 18667170, 18668170, 19209274 |
| Model numbers | 5694302001 |
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 for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0044-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.