Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066001
Check against the official notice below — it lists the full affected range.
Siemens Healthcare Diagnostics is recalling Atellica IM 1300 Analyzers due to a manufacturing defect in valves that may cause them to malfunction, wear, and leak over time. The defect affects valves subject to high pressure or high wear and may impact the accuracy of assay results produced by the analyzer. The recall affects 233 units in the United States and 233 units outside the United States, distributed nationwide and internationally across numerous countries.
The affected devices have serial numbers within the ranges IM00873 to IM01452 and IRM00256xxxx to IRM01169xxxx (where xxxx represents any number). The source document does not specify a remedy or recommended action for consumers.
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: 233 OUS: 233 Lot/code info: Effected Serial Range: IM00873 IM01452 and IRM00256xxxx IRM01169xxxx Note: xxxx in serial number is any number. UDI: 00630414007960
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.