FDA-Device2016-11-23Class III
Dimension Vista IRON Flex reagent cartridges
Siemens Healthcare Diagnostics, Inc.
Hazard
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).
Sold states
Distributed Nationwide
Affected count
30,247 units
Manufactured in
500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, United States
Products
Dimension Vista IRON Flex reagent cartridges
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0401-2017Don't want to check this manually?
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