PSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers, Catalog Numbers LKPS1, LKPS5 and LKPTS1(D); and in the IMMULITE 2000/2000XPi Systems Analyzers, Catalog Numbers L2KPS2, L2KPS6, L2KPTS2(D) and L2KPTS6(D). IVD Immunoassay kits in the following sizes: 100, 200, 500 and 600 test kits; For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and the IMMULITE 2000/ 2000 XPi Systems Analyzers. PMA # P930027/ Device Listing # D002374. Product Usage: For the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. This assay is further indicated as an adjunctive test to aid in the management of prostate cancer patients. For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and the IMMULITE 2000/ 2000 XPI Systems Analyzers

Recall details

Manufacturer

Siemens Healthcare Diagnostics

Distributor

Worldwide Distribution - USA Nationwide including Puerto Rico and the countries of: Albania, Afghanistan, Algeria, Argentina, Austria, Bangladesh, Belgium, Bolivia, Bosnia- Herzegovinia, Brazil, Bulgaria, Camaroon, Canada, Canary Islands, Chile, China, Colombia, Coast Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Great Britain, Greece, Guatemala, Honduras, Hungary, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Malta, Mexico, Morocco, Nicaragua, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, Spain, South Africa, Rep. of Korea (S), Sweden, Switzerland, Syria, Taiwan, Thailand, The Netherlands, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, Uruguay, White Russia, Venezuela, and Vietnam.

Lot

Product Code/Lot # LKPS1 424, Expiration Date 2013-08-31; Product Code/Lot # LKPS1 425, Expiration Date 2013-10-31; Product Code/Lot # LKPS1 426, Expiration Date 2013-10-31; Product Code/Lot # LKPS5 424, Expiration Date 2013-08-31; Product Code/Lot # LKPS5 425, Expiration Date 2013-10-31; Product Code/Lot # LKPS5 426, Expiration Date 2013-10-31; Product Code/Lot # LKPTS1(D) D0104, Expiration Date 2013-08-31; Product Code/Lot # L2KPS2 379, Expiration Date 2013-07-31; Product Code/Lot # L2KPS2 380, Expiration Date 2013-08-31; Product Code/Lot # L2KPS2 381, Expiration Date 2013-10-31; Product Code/Lot # L2KPS2 382, Expiration Date 2013-10-31; Product Code/Lot # L2KPS2 383, Expiration Date 2013-10-31; Product Code/Lot # L2KPS2 384, Expiration Date 2013-10-31; Product Code/Lot # L2KPS6 379, Expiration Date 2013-07-31; Product Code/Lot # L2KPS6 380, Expiration Date 2013-08-31; Product Code/Lot # L2KPS6 381, Expiration Date 2013-10-31; Product Code/Lot # L2KPS6 382, Expiration Date 2013-10-31; Product Code/Lot # L2KPS6 383, Expiration Date 2013-10-31; Product Code/Lot # L2KPS6 384, Expiration Date 2013-10-31; Product Code/Lot # L2KPTS2(D) D107, Expiration Date 2013-07-31; Product Code/Lot # L2KPTS2(D) D108, Expiration Date 2013-10-31; Product Code/Lot # L2KPTS2(D) D109, Expiration Date 2013-10-31; Product Code/Lot # L2KPTS6(D) D107, Expiration Date 2013-07-31; Product Code/Lot # L2KPTS6(D) D108, Expiration Date 2013-10-31; Product Code/Lot # L2KPTS6(D) D109, Expiration Date 2013-10-31.

Risk classification

Class II

Area (FDA)

device

Country

United States