c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 module: Immunoassay Ana...
FDA Recall #Z-1268-2018 — Class II — December 18, 2017
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.
Recalling Firm
Roche Diagnostics Corporation — Indianapolis, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Distribution
US Nationwide
Code Information
None
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated