Dimension Vista¿ Mass CKMB Isoenzyme Calibrator — Class II medical device recall Z-0024-2015
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2014-10-15, distributed nationwide. Siemens Healthcare Diagnostics has determined that Dimension Vista® Mass CKMB Isoenzyme Calibrator (MMB CA
| Recall number | Z-0024-2015 |
|---|---|
| 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 | 2014-08-28 |
| Classified | 2014-10-06 |
| Reported by FDA | 2014-10-15 |
| Terminated | 2015-03-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, DE, DK, ES, FI, FR, IT, JP, KR, NL, NZ, PT, SA, SI |
| Quantity | 6,562 |
| Reason classes | potency, specification failure |
| Lot numbers | 3JD045, 4BD064, 4CD012, 4DD065 |
| Expiration dates | 2014-10-01, 2015-02-01, 2015-03-01, 2015-05-01 |
Product
Dimension Vista¿ Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista¿ System.
Reason for recall
Siemens Healthcare Diagnostics has determined that Dimension Vista® Mass CKMB Isoenzyme Calibrator (MMB CAL) shows drift during routine stability monitoring that exceeds our acceptance criteria for drift over the shelf life of this product. Siemens has observed drift from 3% to 12% at MMB concentrations across the assay range. Depending on quality control limits, this drift may not have been d
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-0024-2015. 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.