Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an in vitro diagnostic product for the calibration of…

Recall date

November 9, 2017

Source

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

Recall number

Z-1184-2018

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics, Inc.

Sold / distributed

Worldwide Distribution: US (nationwide) and countries of: Austria, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Slovakia, Spain and Switzerland.

Why it was recalled

An increase in the number of failed calibration events or negative bias with Quality Control (QC) and patient samples when using Dimension Vista LOCI 8 Calibrator lot 7CD076 to calibrate Estradiol (E2) Assay.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an in vitro diagnostic product for the calibration of follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL), and estradiol (E2) methods on the Dimension Vista System.