Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Dimension Vista¿ Mass CKMB Isoenzyme Calibrator (MMB CAL) an in Recalled by Siemens Healthcare Diagnostics, Inc. Due to Siemens Healthcare Diagnostics has determined that Dimension Vista®...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Siemens Healthcare Diagnostics, Inc. directly.
Affected Products
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.
Quantity: 6562
Why Was This Recalled?
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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Siemens Healthcare Diagnostics, Inc.
Siemens Healthcare Diagnostics, Inc. has 452 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report