Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066000
Check against the official notice below — it lists the full affected range.
Siemens Healthcare Diagnostics, Inc. is recalling Atellica IM 1600 Analyzers and related component systems used for in vitro diagnostic testing of clinical specimens. The recall affects valves on the Atellica CH 930, Atellica IM 1300, and Atellica IM 1600 analyzers that may develop a manufacturing defect causing them to wear and leak over time. The leaking poses a risk in valves subject to high pressure or high wear conditions and may impact the accuracy of assay results.
A total of 123 units were distributed in the United States and 751 units were distributed outside the U.S. across numerous countries. The affected devices have serial numbers in the ranges IH00876 through IH01451 and IRH00258xxxx through IRH01169xxxx (where xxxx represents any number). The source record does not specify a remedy for affected 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: 123 OUS: 751 Lot/code info: Effected serial range: IH00876 IH01451 and IRH00258xxxx IRH01169xxxx Note: xxxx in serial number is any number. UDI: 00630414002026
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.