Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista IRON Flex reagent cartridges
- Recall date
- August 25, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0401-2017
- FDA classification
- Class III
- Brand / firm
- Siemens Healthcare Diagnostics, Inc.
- Sold / distributed
- Distributed Nationwide
Why it was recalled
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).
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Dimension Vista IRON Flex reagent cartridges
Get recall alerts
Free email alert whenever Siemens Healthcare Diagnostics, Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Siemens Healthcare Diagnostics, Inc.