FDA recall Z-0044-2020

Roche Diagnostics Operations, Inc. · Class II · 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

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

Nationwide

Key facts

Status: Terminated
Initiation date: 2019-08-13
Report date: 2019-10-16
Termination date: 2022-06-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0044-2020