Z-0044-2020 Class II Terminated
FDA device recall Z-0044-2020 was initiated by Roche Diagnostics Operations, Inc. on August 13, 2019 and is designated Class II. 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 The recall status is terminated (terminated June 30, 2022). Affected quantity: 935 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 16, 2019
- Initiation Date
- August 13, 2019
- Termination Date
- June 30, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 935 units
Product Description
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
Distribution Pattern
Nationwide
Code Information
Lot Numbers: 18636170 18665170 18667170 18668170 18215274 18245274 18250274 18251274 18252274 18253274 18265274 18271274 19209274