FDA-Device2019-10-16Class II
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
Roche Diagnostics Operations, Inc.
Hazard
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
Sold states
Nationwide
Affected count
935 units
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0044-2020Don't want to check this manually?
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