Siemens Healthcare Diagnostics, Inc recalls Dimension Vista LOCI Progesterone; Catalog Number: K6464; Siemens Material Number: 10461743 Product Usage: For in vitro…

Recall date

January 4, 2017

Source

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

Recall number

Z-1419-2017

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics, Inc

Sold / distributed

US Nationwide distribution including Puerto Rico

Why it was recalled

DHEA-S causes falsely elevated progesterone results.

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 LOCI Progesterone; Catalog Number: K6464; Siemens Material Number: 10461743 Product Usage: For in vitro diagnostic use in the quantitative determination of progesterone in serum and using the ADVIA Centaur¿, ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems