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Recall Observatory FDA recall evidence

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

November 24, 2014

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
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

    reason.no_named_rule · v1.0.0

    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.