Siemens Total Iron Binding Capacity — Class III medical device recall Z-0933-2013
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2013-03-20, distributed nationwide. The analytical sensitivity claim of 6 ug/dL (1.1 umol/L) in the Instructions for Use (IFU) is no longer valid.
| Recall number | Z-0933-2013 |
|---|---|
| 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 | 2012-12-20 |
| Classified | 2013-03-11 |
| Reported by FDA | 2013-03-20 |
| Terminated | 2014-08-26 |
| Distributed | Nationwide (US) |
| Lot numbers | BA3016, BB3184, DC3102, EA3073, EA3157, EC3045, EC3219, EC3220, FB3290, FC3122, GA3248 |
| Model numbers | DF84 |
| Expiration dates | 2013-01-16, 2013-02-14, 2013-03-14, 2013-04-12, 2013-05-02, 2013-06-06, 2013-07-03, 2013-08-07, 2013-08-08, 2013-10-17 |
Product
Siemens Total Iron Binding Capacity (IBCT) Flex Reagent Cartridge. An in vitro diagnostic test intended to quantitatively measure Total Iron Binding Capacity in human serum.
Reason for recall
The analytical sensitivity claim of 6 ug/dL (1.1 umol/L) in the Instructions for Use (IFU) is no longer valid. Siemens is conducting a voluntary corrective action for Dimension Total Iron Binding Capacity (IBCT) to modify the analytical sensitivity claim to 36 ug/dL (6.44 umol/L).
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-0933-2013. 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.