RecallWatchUSA

Home / Recalls / Medical Devices

Siemens Healthcare Diagnostics, Inc recalls IMMULITE 2000 Progesterone; Catalog Number: L2KPW2 L2KPW6; Siemens Material Number: 10381181, 10381170 Product Usag

Recalled March 15, 2017 · FDA recall Z-1421-2017 · Siemens Healthcare Diagnostics

Hazard
DHEA-S causes falsely elevated progesterone results. · FDA Class II
Units
11963
Sold at
US Nationwide distribution including Puerto Rico

Description

DHEA-S causes falsely elevated progesterone results.

Product
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.
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Siemens Healthcare Diagnostics, Inc recalls IMMULITE 2000 Progesterone; Catalog Number: L2KPW2 L2KPW6; Siemens Material Number: 10381181, 10381170 Product Usag | RecallWatchUSA