FDA-Device2017-03-15Class II
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.
Siemens Healthcare Diagnostics, Inc
Hazard
DHEA-S causes falsely elevated progesterone results.
Sold states
US Nationwide distribution including Puerto Rico
Affected count
76,107
Manufactured in
333 Coney St, N/A, East Walpole, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1418-2017Don't want to check this manually?
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