Siemens Recalls Dimension Vista Mass CKMB Isoenzyme Calibrator Due to Drift
Siemens Healthcare Diagnostics is recalling Dimension Vista Mass CKMB Isoenzyme Calibrators because routine stability monitoring showed drift exceeding acceptance criteria.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score. The hazard involves potential calibration drift in an in vitro diagnostic, which is a quality issue rather than a direct physical injury or acute health threat.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL), an in vitro diagnostic product used for the calibration of the Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System. The recall involves 6,562 units distributed worldwide, including the United States and various international markets.
The recall was initiated because the product showed drift during routine stability monitoring that exceeded the manufacturer's acceptance criteria for drift over the product's shelf life. Siemens observed drift ranging from 3% to 12% at MMB concentrations across the assay range. The source text notes that depending on quality control limits, this drift may not have been detected.
The affected lots are 3JD045 (exp. 2014-10-01), 4BD064 (exp. 2015-02-01), 4CD012 (exp. 2015-03-01), and 4DD065 (exp. 2015-05-01). Users of these products should contact Siemens Healthcare Diagnostics for further instructions on the recall.
The recalled product
- 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.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 6,562
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- 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.
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Siemens Healthcare Diagnostics, Inc.
See all →- SevereSiemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
- SevereSiemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
- HighSiemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
- ModerateSiemens Tricyclic Antidepressant Calibrator/Controls Recall Lot U2
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · calibration drift
See all →- HighLandauer microSTARii reader recalled for measurement inaccuracy
FDA (Devices) · 2024-01-03
- HighMedfusion Syringe Pump Recalled for Occlusion Detection Calibration Drift
FDA (Devices) · 2023-10-18
- HighMedfusion Syringe Pump Sensor Calibration Drift May Cause False Alarms
FDA (Devices) · 2023-10-18
- HighMedfusion Infusion Pump Plunger Sensor Calibration Drift Recall
FDA (Devices) · 2023-10-18
- HighMedfusion Syringe Pumps Recalled for Force Sensor Calibration Drift
FDA (Devices) · 2023-10-18