FDA (Devices) recall action 75256
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
Siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and Dimension Vista IRON assays at a different concentration than listed in the Instructions for Use (IFU).
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Siemens Healthcare Diagnostics is recalling Dimension IRON Flex reagent cartridges because deferoxamine interferes with the assay at a different concentration than listed in the instructions.
Siemens Healthcare Diagnostics is recalling Dimension Vista IRON Flex reagent cartridges due to deferoxamine interference at concentrations not listed in the Instructions for Use.