Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0946-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 24, 2014

Date Posted: January 14, 2015

Recall Number: Z-0946-2015

Event ID: 69937

Reason for Recall:

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.

Status: Terminated

Product Quantity: 1230

Code Information:

Lot 4FD085, exp. 12-01-2014

Distribution Pattern:

Worldwide Distribution: US (nationwide) and country of: Canada.

Voluntary or Mandated:

Voluntary: Firm initiated