FDANovember 24, 2014device
Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 Product usage: in vitro diagnostic product for the calibration of Myoglobin (MYO) method on the Dimension Vista System.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Dimension Vista Myoglobin Calibrator (MYO CAL) may produce a positive shift in MYO QC and Patient test results that exceeds acceptance criteria for this product. A positive shift observed up to 12% at MYO concentrations within and above the reference range of the assay. Depending on quality control limits, this drift may not be detected.
What to do
FDA enforcement status: Terminated
Brands named
siemens healthcare diagnosticssiemenssiemens healthcare
Recall history
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