FDA Device recall Z-0024-2015
Dimension Vista¿ Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzym…
- FDA Device
- Class II
- terminated
- Published 2014-10-15
On 2014-10-15 the FDA classified a Class II recall of Dimension Vista¿ Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzym… by Siemens Healthcare Diagnostics, citing siemens Healthcare Diagnostics has determined that Dimension Vista® Mass CKMB Isoenzyme Calibrator (MMB CAL) shows drift during routine stability monitoring that exceeds our a….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0024-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-08-28 |
| Published | 2014-10-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
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
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
Identifiers
| code_info | lot 3JD045, exp. 2014-10-01; lot 4BD064, exp. 2015-02-01; lot 4CD012, exp. 2015-03-01; and lot 4DD065, exp. 2015-05-01. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0024-2015%22
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