Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an… recallZ-0024-2015 · Siemens Healthcare Diagnostics, Inc. · initiated Aug 28, 2014
Class II Terminated All recalls posted in October 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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
FDA root cause category: Process design
What the company is doing
An Urgent Medical Device Recall notice, dated August 2014, was provided to all Dimension Vista MMB CAL customers who received the affected lots to notify them of the issue, the potential risk to health, and actions to be taken by customers. Customers were instructed to discard lots 3JD045, 4BD064, 4CD012, and 4DD065, and recalibrate with lot 4FD073.
Recall details
- Recall number
- Z-0024-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 28, 2014
- Posted by the FDA
- Oct 6, 2014
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 6562
- Product code
- JIT
- FDA submissions
- K051087
- Distribution
- Worldwided distribution: US (nationwide) and countries of: Australia, Austria, Belgium, Canada, Denmark, Germany, Finland, France, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, Slovenia, South Korea, Spain, and Switzerland.
Product description
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.
Code information (models, lots, serial numbers)
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.
Other devices under the same FDA submission
4 devices cleared under K051087 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Dimension Vista® 500 10284473Siemens Healthcare Diagnostics Inc. · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE1 recall524 reports
- Dimension Vista® 500 Intelligent Lab System 10488217Siemens Healthcare Diagnostics Inc. · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE13 reports
- Dimension Vista® V-LYTE® Integrated Multisensor Na+ / K+ / Cl- 10484429Siemens Healthcare Diagnostics Inc. · ELECTRODE, ION SPECIFIC, POTASSIUM10 reports
- Dimension Vista® 1500 Intelligent Lab System 10459469Siemens Healthcare Diagnostics Inc. · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE9 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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