Dimension IRON Flex reagent cartridges
Reported: November 23, 2016 Initiated: August 25, 2016 #Z-0402-2017
Product Description
Dimension IRON Flex reagent cartridges
Reason for Recall
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).
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 38,230 cartridges
- Distribution
- Distributed Nationwide
- Location
- Newark, DE
Frequently Asked Questions
What product was recalled? ▼
Dimension IRON Flex reagent cartridges. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 38,230 cartridges.
Why was this product 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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 23, 2016. Severity: Low. Recall number: Z-0402-2017.
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