Reported Oct 15, 2014 · Terminated
Dimension Vista¿ Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of…
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 500 Gbc Dr Ms 514 · Newark, DE · 19702-2466
Is this the product you have?
- 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.
- Lot codes and dates
lot 3JD045exp. 2014-10-01lot 4BD064exp. 2015-02-01lot 4CD012exp. 2015-03-01and lot 4DD065exp. 2015-05-01
- Amount recalled
- 6562
Where it was sold
- Nationwide
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
This product could cause temporary or reversible health problems — stop using it.
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