Roche Diagnostics Corporation recalls Modular E 170 Analyzer: Immunoassay Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use, Catalog Num…
- Recall date
- December 18, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1269-2018
- 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 sample 13 mm 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
Modular E 170 Analyzer: Immunoassay Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use, Catalog Numbers: 03739040692, 03023109001, 05023599001, 05023572001, 03739040001 & 03023109973.
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