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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