Medical device recalls Moderate risk

Roche Diagnostics Operations, Inc. recalls cobas c513 Analyzer

Recall date
July 18, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2478-2019
FDA classification
Class II
Brand / firm
Roche Diagnostics Operations, Inc.
Sold / distributed
State NY MT HI IN MD TX OH KS KY CA FL OR LA MO AK

Why it was recalled

Quality issue with high pressure solenoid valves

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 c513 Analyzer

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