Dimension IRON Flex reagent cartridges — Class III medical device recall Z-0402-2017
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2016-11-23, distributed nationwide. Siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and Dimension Vist
| Recall number | Z-0402-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2016-08-25 |
| Classified | 2016-11-11 |
| Reported by FDA | 2016-11-23 |
| Terminated | 2017-12-01 |
| Distributed | Nationwide (US) |
| Quantity | 38,230 cartridges |
| Lot numbers | 0-7/19/2017, BA7006, BA7116, BB7006, DB6267, EC7200, FB6310, FD6309, GB7060 |
| Expiration dates | 2016-09-23 |
Product
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0402-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.