Z-1269-2018 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

Modular E 170 Analyzer: Immunoassay Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use, Catalog Numbers: 03739040692, 03023109001, 05023599001, 05023572001, 03739040001 & 03023109973.

Reason for Recall

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

Distribution Pattern

US Nationwide

Code Information

None