CLASS II Device recall · Reported 15 Oct 2014 · FDA Enforcement Report
Dimension Vista¿ Mass CKMB Isoenzyme Calibrator recalled
Siemens Healthcare Diagnostics is recalling Dimension Vista¿ Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product, distributed nationwide in the US. The recall was initiated on 28 Aug 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0024-2015
- FDA event ID
- 69149
- Recalling firm
- Siemens Healthcare Diagnostics, Newark, DE
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Aug 2014
- FDA classified
- 6 Oct 2014
- Reported
- 15 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 28 Aug 2014 | Recall initiated by company | |
| 6 Oct 2014 | Classified by FDA | +39 days |
| 15 Oct 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
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.
Questions about this recall
Why was it 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
Which lots are affected?
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.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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