Dimension — Class III medical device recall Z-0745-2013
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2013-02-06, distributed nationwide. Siemens Healthcare Diagnostics has received complaints of IRON calibrations outside of acceptable calibration
| Recall number | Z-0745-2013 |
|---|---|
| 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 | 2013-01-28 |
| Reported by FDA | 2013-02-06 |
| Terminated | 2014-01-08 |
| Distributed | Nationwide (US) |
| Quantity | 5,999 |
| Lot numbers | 2DN060, 2FN063, 2GN068, 2JN073 |
| Expiration dates | 2013-10-01, 2013-12-01, 2014-01-01, 2014-03-01 |
Product
Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010. The Dimension(R) IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the Iron method for the Dimension(R) clinical chemistry system.
Reason for recall
Siemens Healthcare Diagnostics has received complaints of IRON calibrations outside of acceptable calibration slope (m) values (0.97 - 1.03) when using IRON calibrator lots 2DN060 and 2FN063. Lots 2GN068 and 2JN074 may also be impacted but no complaints have been received.
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-0745-2013. 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.