Device 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
Z-0044-2020
Product summary
- Event
- Event 83646
- Status
- Terminated
- Classification
- Class II
- Quantity
- 935 units
- Official record key
device-enforcement:Z-0044-2020
Official wording
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
Code information: Lot Numbers: 18636170 18665170 18667170 18668170 18215274 18245274 18250274 18251274 18252274 18253274 18265274 18271274 19209274
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
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