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Siemens Healthcare Diagnostics, Inc. recalls The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI and ALTI
Recalled February 22, 2017 · FDA recall Z-1216-2017 · Siemens Healthcare Diagnostics
Hazard
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. · FDA Class III
Units
13,147 units
Sold at
Distributed throughout the United States
Description
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.
Product
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.
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →