Dimension — Class II medical device recall Z-1925-2013
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2013-08-14, distributed nationwide. Siemens Healthcare Diagnostics has received complaints that the lyophilized cake is not fully dissolved after
| Recall number | Z-1925-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2013-06-05 |
| Classified | 2013-08-07 |
| Reported by FDA | 2013-08-14 |
| Terminated | 2015-03-18 |
| Distributed | Nationwide (US) |
| Quantity | 7,470 |
| Lot numbers | 2GD053, 2KD024, 3AD051 |
| Model numbers | RC420 |
Product
Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) The Mass Creatine Kinase MB isozyme Calibrator is an in vitro diagnostic product intended to be used to calibrate the Creatine Kinase MB Isozyme method for the Dimension(R) clinical chemistry system with heterogeneous immunoassay module.
Reason for recall
Siemens Healthcare Diagnostics has received complaints that the lyophilized cake is not fully dissolved after the stated time in the MMB calibrator Instructions For Use (IFU). The frequency of this occurrence is low but if it occurs, gel-like clumps may be observed.
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-1925-2013. 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.