Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1216-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI and ALTI) and Aspartate Aminotransferase (AST) methods on the Dimension Vista System. For prescription use only.

Product Classification:

Class III

Date Initiated: May 5, 2016

Date Posted: February 22, 2017

Recall Number: Z-1216-2017

Event ID: 76293

Reason for Recall:

Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the Dimension Vista Enzyme 2 calibrator. Internal investigation has confirmed that patient samples and QC material demonstrate a shift of up to 10% in comparison to results obtained using earlier calibrator lots.

Status: Terminated

Product Quantity: 13,147 units

Code Information:

Lot Number: 4MD048, 5DD026, 5ED071, 5GD004, 5JD058, 5LD061

Distribution Pattern:

Distributed throughout the United States

Voluntary or Mandated:

Voluntary: Firm initiated