Medical device recalls Moderate risk

Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111 Product Usage: The PROG method is an in vitro di…

Recall date
January 4, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1418-2017
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

ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111 Product Usage: The PROG method is an in vitro diagnostic test for the quantitative measurement of progesterone in human serum and plasma on the Dimension Vista¿System. Progesterone measurements are used in the diagnosis and treatment of disorders of the ovaries or placenta.

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