Lower riskMedical device recall · FDA · Published September 22, 2025
Siemens IMMULITE 2000 Intact PTH Test May Give False Low Results
Siemens Healthcare recalls specific lots of IMMULITE 2000 Intact PTH tests that may produce falsely low PTH results, affecting patient diagnosis. Check your test lot numbers to see if affected.
The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal to 5.3 pmol/L), when using specific lots identified by the firm on the IMMULITE 2000/IMMULITE 2000 XPi systems. The bias is observed in both serum and plasma samples.
Take action
Contact the company
📍Recalling firmSiemens Healthcare Diagnostics, Inc.333 Coney St · East Walpole, MA 02032-1516
“Siemens IMMULITE 2000 Intact PTH Test May Give False Low Results.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51245-siemens-immulite-2000-intact-pth-test-may-give-false-low. Based on FDA recall #Z-0366-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0366-2026%22&limit=1).
The FDA announced on September 22, 2025, that Siemens Healthcare Diagnostics, Inc. is recalling specific lots of its IMMULITE 2000 Intact PTH assay due to the potential for falsely depressed patient results. The agency issued recall number Z-0366-2026 for the Class II voluntary recall.
How to tell if you have it
Brand: Siemens Healthcare
Product: Assay: IMMULITE 2000 Intact PTH; Test Code: iPT
Siemens Material Number (SMN): 10381441, 10381442
Catalog Number: L2KPP2, L2KPP6
Lot Numbers: 385, 387, 388, 389
Units affected: 3318
The hazard
The recall addresses the potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal to 5.3 pmol/L), when using specific lots on the IMMULITE 2000/IMMULITE 2000 XPi systems. The bias is observed in both serum and plasma samples.
Context
GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has 150 other recalls on record since 2017-06-07. Other recent recalls of similar products include Atellica CH Revised C-Reactive Protein (RCRP) Recall (2026-08-17), Beckman Coulter Emit 2000 Quinidine Assay Recall (2026-07-13), and Siemens Atellica CH Urine Albumin Recall (2026-07-06). Other recent recalls of similar products include Siemens Healthineers Immulite 2000 Syphilis Screen Recall (2026-07-13), LH One Step Ovulation Test Device Recall (2025-11-22), and Beckman Coulter Access Total T4 Calibrator Recall (2026-03-16).
How to tell if you have this one
Check the lot number on your test kit. Affected lots are 385, 387, 388, and 389 for both material numbers 10381441 and 10381442. These were sold with catalog numbers L2KPP2 and L2KPP6.
Brand
Siemens Healthcare
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Test Lot Number
Look for the lot number on your IMMULITE 2000 Intact PTH test kit. Affected lots are 385, 387, 388, and 389.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 12 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide distribution in the states of AL, CA, DC, FL, ID, IN, LA, MD, NC, NJ, NY, PA, SC and the countries of Argentina, Australia, Bolivia, Bosnia Herzeg, Brazil, Bulgaria, Canada, Chile, Colombia, Cyprus, Czech…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, District of Columbia, Florida, Idaho, Indiana, Louisiana, Maryland, New Jersey, New York, North Carolina, Pennsylvania, South Carolina.
Recall timeline
FDA published this recall 44 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-0366-2026 (September 22, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0366-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.