Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11067000
Check against the official notice below — it lists the full affected range.
Siemens Healthcare Diagnostics is recalling Atellica CH 930, Atellica IM 1300, and Atellica IM 1600 analyzers due to a manufacturing defect in valves that may develop malfunctions over time. The defective valves may wear and leak, which poses a risk in valves subject to high pressure or high wear conditions and could impact the accuracy of assay results. The recall affects 210 units in the United States and 874 units internationally across numerous countries, with serial numbers ranging from CM00902 to CM02065.
The source document does not specify a remedy or what affected consumers should do in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Nationwide Foreign: Country Name Algeria Argentina Australia Austria Bahrain Bangladesh Belgium Brazil Bulgaria Burkina Faso Canada Chile Colombia Croatia Cura¿ao Cyprus Czech Republic Denmark Ecuador Egypt Estonia Finland France Germany Greece Hungary India Indonesia Iraq Ireland Israel Italy Japan Kenya Kuwait Latvia Libya Lithuania Malaysia Mexico Morocco Netherlands New Zealand Norway Oman P.R Quantity: US: 210 OUS: 874 Lot/code info: Effected SN Range: CM00902 - CM02065 Note: xxxx in serial number is any number. UDI: 00630414002163
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.