Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066000

Reason: 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.

Code information: Effected serial range: IH00876 IH01451 and IRH00258xxxx IRH01169xxxx Note: xxxx in serial number is any number. UDI: 00630414002026

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