Siemens Healthcare recalls IMMULITE 2000 PSA assay kits with specific catalog numbers due to potential high-dose hook effect issues in test results. Affected units may produce inaccurate results; contact for details.
The IMMULITE 2000 PSA assay for use on the IMMULITE 2000 and IMMULITE 2000 XPi analyzers did not meet the High-dose Hook Effect claim as stated in the Instructions for Use (IFU).
Take action
Contact the company
📍Recalling firmSiemens Healthcare Diagnostics, Inc.333 Coney St · East Walpole, MA 02032-1516
✎ GovInfoNow plain-language explainer
Siemens Healthcare is recalling two specific versions of the IMMULITE 2000 PSA assay kits because they may not work correctly for high-dose samples, leading to inaccurate test results. This could affect the reliability of prostate cancer screening tests. Read more at govinfonow.com/recall/53845-siemens-immulite-2000-psa-assay-recall-high-dose-hook-effect.
“Siemens IMMULITE 2000 PSA Assay Recall: High-dose Hook Effect Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/53845-siemens-immulite-2000-psa-assay-recall-high-dose-hook-effect. Based on FDA recall #Z-0464-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0464-2025%22&limit=1).
The FDA announced on Sept. 30, 2024, that Siemens Healthcare Diagnostics, Inc. is recalling IMMULITE 2000 PSA assays because they did not meet the High-dose Hook Effect claim stated in the Instructions for Use. The recall affects 7,332 units distributed worldwide.
How to tell if you have it
Brand: Siemens Healthcare
Product: IMMULITE 2000 PSA assay
Catalog Number L2KPTS2(D) (SMN 10706281): UDI - 00630414982212, Lot Number D164
Catalog Number L2KPTS6(D) (SMN 10706282): UDI - 00630414982229, Lot Number D166
SMN 10380896 (OUS): UDI - 00630414961958
SMN 10380996 (OUS): UDI - 00630414961965
OUS Lot Numbers: 438, 439, 440
The hazard
According to the FDA, the IMMULITE 2000 PSA assay for use on the IMMULITE 2000 and IMMULITE 2000 XPi analyzers did not meet the High-dose Hook Effect claim as stated in the Instructions for Use.
Context
GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has 150 other recalls on record since June 7, 2017. Other recent recalls of similar products include Siemens Atellica CH RCRP Test (Aug. 17, 2026), Beckman Coulter Emit 2000 Quinidine Assay (July 13, 2026), and Siemens Atellica CH Urine Albumin Recall (July 6, 2026). Other recent recalls of similar products include Siemens Healthineers Immulite 2000 Syphilis Screen (July 13, 2026), Immunotech Estrone RIA Kit (Dec. 15, 2025), and Siemens ARTIS pheno and Icono Biplane X-Ray Recalls (March 10, 2026).
How to tell if you have this one
Check for catalog numbers L2KPTS2(D) (SMN 10706281) or L2KPTS6(D) (SMN 10706282) on the kit packaging. The lot numbers D164 or D166 are also associated with these kits.
Brand
Siemens Healthcare
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Details
Review the catalog number and lot number on the assay kit packaging to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide - US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 51 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0464-2025 (September 30, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0464-2025 to see it in context.
Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.