Medical device recalls Moderate risk

Roche Diagnostics Corporation recalls c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 module: Immunoassay Analyzer, Catalog Numbers…

Recall date
December 18, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1268-2018
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 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

c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 module: Immunoassay Analyzer, Catalog Numbers: 04745922001, 05036348001, 05860652001, 04745922692, 05036348001 & 05036348692

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