FDA-Device2017-03-15Class II
IMMULITE 2000 Progesterone; Catalog Number: L2KPW2 L2KPW6; Siemens Material Number: 10381181, 10381170 Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 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
11963
Manufactured in
333 Coney St, N/A, East Walpole, MA, United States
Products
IMMULITE 2000 Progesterone; Catalog Number: L2KPW2 L2KPW6; Siemens Material Number: 10381181, 10381170 Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 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-1421-2017Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief