FDA Device recall Z-0402-2017
Dimension IRON Flex reagent cartridges
- FDA Device
- Class III
- terminated
- Published 2016-11-23
On 2016-11-23 the FDA classified a Class III recall of Dimension IRON Flex reagent cartridges by Siemens Healthcare Diagnostics, citing siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and Dimension Vista IRON assays at a different concentration than listed in the Instruc….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0402-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-08-25 |
| Published | 2016-11-23 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Dimension IRON Flex reagent cartridges
Reason
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).
Identifiers
| code_info | Device Listing # D011391 Lot # DB6267, FD6309, FB6310,BA7006,BB7006,GB7060,BA7116,EC7200 Exp Date: 09/23/2016-0-7/19/2017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0402-2017%22
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