Siemens Mass Creatine Kinase MB Isozyme Calibrator Recalled for Dissolution Issues
Siemens Healthcare Diagnostics is recalling 7,470 units of the Dimension Mass Creatine Kinase MB Isozyme Calibrator because the lyophilized cake may not fully dissolve.
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, and the hazard involves a functional defect (incomplete dissolution) that may affect diagnostic accuracy but does not involve reported injuries or high-risk pathogens.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 7,470 units of the Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420). The affected product is an in vitro diagnostic calibrator used for the Dimension(R) clinical chemistry system. The recall involves specific lots: 2GD053, 2KD024, and 3AD051, with catalog number RC420 and Siemens material number 10445023.
The recall was initiated after the manufacturer received complaints that the lyophilized cake in the calibrator does not fully dissolve within the time stated in the Instructions For Use (IFU). When this occurs, gel-like clumps may be observed. The company notes that the frequency of this occurrence is low.
The product was distributed nationwide across the United States, including all 50 states, the District of Columbia, Puerto Rico, and Guam. Users of the Dimension(R) clinical chemistry system should check their inventory for the affected lot numbers and stop using the product if it matches the recalled items.
The recalled product
- 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 heterogen
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 7,470
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 (5)
- Product - MMB CAL
- Catalog Number RC420
- Siemens Material Number 10445023 with lot numbers 2GD053
- 2KD024
- and 3AD051.
Distribution
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 · incomplete dissolution
See all →- ModerateBaxter Recalls COSEAL Surgical Sealant Kits Due to Dissolution Issues
FDA (Devices) · 2016-06-08
- ModerateBaxter Recalls COSEAL Surgical Sealant Kits Due to Dissolution Issues
FDA (Devices) · 2016-06-08
- ModerateBaxter Recalls COSEAL Surgical Sealant Kits Due to Dissolution Issues
FDA (Devices) · 2016-06-08