Home / Recalls / Roche Diagnostics Corporation / Z-1270-2018

Z-1270-2018 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

cobas e 411 Immunoassay Analyzer (Discrete Photometric Analyzer for Clinical use), Catalog Numbers: 04775201001 (rack system), 04775279001 (disk system), 04775201973 (rack system) & 04775279973 (disk system).

Reason for Recall

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

Distribution Pattern

US Nationwide

Code Information

None

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