FDA (Devices) recall action 79683
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.
When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers
The agency’s own wording, quoted from the enforcement report.
Siemens Healthcare Diagnostics is recalling Atellica Solution and Sample Handler Prime systems because reporting and conversion factors may not apply to all connected analyzers.
Siemens Healthcare Diagnostics is recalling Atelia IM 1300 Analyzers because reporting and conversion factors may not apply to all units when connected to a single solution system.
Siemens Healthcare Diagnostics is recalling Atellica IM 1600 Analyzer systems because reporting and conversion factors may not apply to all connected analyzers.