Siemens Healthcare Diagnostics, Inc. recalls Atellica CH 930 Analyzer - multi-component system for in vi
Recalled Product
Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11067000
Hazard / Issue
Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and leaking over time. The leaking is a risk in valves subject to high pressure or high wear and may impact the result accuracy of any assay.
Issued by
FDA
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