FDA Device recall Z-2047-2013

PSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers, Catalog Numbers LKPS1, LKPS5 and LKPTS1(D)

FDA Device
Class II
terminated
Published 2013-09-04

On 2013-09-04 the FDA classified a Class II recall of PSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers, Catalog Numbers LKPS1, LKPS5 and LKPTS1(D) by Siemens Healthcare Diagnostics, citing 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 10….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2047-2013
Classification	Class II
Status	terminated
Initiated	2013-06-26
Published	2013-09-04
Last updated	2026-09-13 11:53 UTC
Company	Siemens Healthcare Diagnostics
Distribution	US

Product

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

Reason

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.

Identifiers

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 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, Expirat

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 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, Expirat

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2047-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.