Dimension Vista Myoglobin Calibrator — Class II medical device recall Z-0946-2015
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2015-01-14, distributed nationwide. Dimension Vista Myoglobin Calibrator (MYO CAL) may produce a positive shift in MYO QC and Patient test results
| Recall number | Z-0946-2015 |
|---|---|
| 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 | 2014-11-24 |
| Classified | 2015-01-08 |
| Reported by FDA | 2015-01-14 |
| Terminated | 2016-12-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 1,230 |
| Reason classes | potency |
| Lot numbers | 4FD085 |
| Expiration dates | 2014-12-01 |
Product
Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 Product usage: in vitro diagnostic product for the calibration of Myoglobin (MYO) method on the Dimension Vista System.
Reason for recall
Dimension Vista Myoglobin Calibrator (MYO CAL) may produce a positive shift in MYO QC and Patient test results that exceeds acceptance criteria for this product. A positive shift observed up to 12% at MYO concentrations within and above the reference range of the assay. Depending on quality control limits, this drift may not be detected.
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-0946-2015. 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.