Z-1268-2018 Class II Terminated

Recalled by Roche Diagnostics Corporation — Indianapolis, IN

Recall Details

Product Type
Devices
Report Date
April 4, 2018
Initiation Date
December 18, 2017
Termination Date
April 9, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 module: Immunoassay Analyzer, Catalog Numbers: 04745922001, 05036348001, 05860652001, 04745922692, 05036348001 & 05036348692

Reason for Recall

Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 sample tubes without tube adapters.

Distribution Pattern

US Nationwide

Code Information

None