FDA-Device2017-03-15Class II
IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material Number: 10381128 Product Usage: For in vitro diagnostic use with the IMMULITE¿2000 Systems Analyzers- for the quantitative measurement of progesterone in serum, as an aid 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
9076
Manufactured in
333 Coney St, N/A, East Walpole, MA, United States
Products
IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material Number: 10381128 Product Usage: For in vitro diagnostic use with the IMMULITE¿2000 Systems Analyzers- for the quantitative measurement of progesterone in serum, as an aid 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-1420-2017Don't want to check this manually?
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