Modular E 170 Analyzer: Immunoassay Chemistry Analyzer, Chemistry (Photometric, Discrete) for cl...
FDA Recall #Z-1269-2018 — Class II — December 18, 2017
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.
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