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

Recalled April 4, 2018 · FDA recall Z-1270-2018 · Roche Diagnostics

Hazard

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

Sold at

US Nationwide

Description

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

Product

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).

Manufacturer(s)

Roche Diagnostics Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →