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U.S. Department of Health and Human Services

Enforcement Report - Week of September 4, 2013

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Product Detail

Product Description 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 Number Z-2047-2013
Classification Class II
Code Info 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.
Product Distributed Qty 24,361 kits
Reason For Recall Customers complained of a positive bias in patient results on the IMMULITE/ IMMULITE 1000 and the IMMULITE 2000/ 2000 XPi PSA assay when compared against the IMMULITE /IMMULITE 1000 3rd Generation PSA assay. Siemens has confirmed an overall average positive bias of approximately 20% to 23% across the assay range relative to the WHO 96/670 with the IMMMULITE Systems PSA Assay. This positive bias is observed in patient values and the Siemens Tumor Marker controls (TMCO). Other commercially available controls may show this bias.

Event Detail

Event Id 65609
Product Type Devices
Status Ongoing
Recalling Firm Siemens Healthcare Diagnostics
City Tarrytown
State NY
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-26
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern 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.
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