Roche Diagnostics Corporation recalls cobas e 411 Immunoassay Analyzer (Discrete Photometric Analyzer for Clinical use), Catalog Numbers: 04775201001 (rack s…

Recall date

December 18, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1270-2018

FDA classification

Class II

Brand / firm

Roche Diagnostics Corporation

Sold / distributed

US Nationwide

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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).