medical Class II Updated 2019-10-16

Roche Diagnostics Operations, Inc. recalls AssayTip/AssayCup Tray-used on the cobas e 801 module which

Recalled 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


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Numbers: 18636170 18665170 18667170 18668170 18215274 18245274 18250274 18251274 18252274 18253274 18265274 18271274 19209274
View official government recall

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