FDA (Devices) recall action 88056
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
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.
The agency’s own wording, quoted from the enforcement report.
Siemens is recalling Atellica IM 1300 diagnostic analyzer valves due to a manufacturing defect that may cause leaking and affect test result accuracy.
Siemens Healthcare Diagnostics has recalled Atellica CH 930 Analyzer valves that may malfunction due to a manufacturing defect. The affected valves may wear and leak over time, potentially impacting diagnostic test accuracy.
Siemens recalls Atellica analyzers (CH 930, IM 1300, IM 1600) due to valve manufacturing defects that may cause leaking and affect clinical test result accuracy.