Device product
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.
Z-0946-2015
Product summary
- Event
- Event 69937
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1230
- Official record key
device-enforcement:Z-0946-2015
Official wording
Reason: 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.
Code information: Lot 4FD085, exp. 12-01-2014
Distribution pattern: Worldwide Distribution: US (nationwide) and country of: Canada.
Derived failure modes
-
Unknown
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.