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
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