Siemens Healthcare Diagnostics, Inc. recalls The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine Aminotransferase (ALTI) on the Dimension¿ cl…

Recall date

May 5, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1217-2017

FDA classification

Class III

Brand / firm

Siemens Healthcare Diagnostics, Inc.

Sold / distributed

Distributed throughout the United States

Why it was recalled

Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the Dimension Enzyme II 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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine Aminotransferase (ALTI) on the Dimension¿ clinical chemistry system. For prescription use only.