Z-0366-2026Class II

Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442...

Name: Z-0366-2026 Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2025-09-22
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2025-09-22 / Open, Classified

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6 on 2025-09-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0366-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-22
Posted: 2025-10-27
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6;
Product code: CEW Radioimmunoassay, Parathyroid Hormone
Reason for recall: 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.
FDA root cause: Under Investigation by firm
Action: On September 22, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Customer Actions: Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. Discontinue use of and discard the kit lot listed in the table above (Products Section). Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. For continued Intact PTH testing in your laboratory during this time, please contact your Siemens representative to discuss alternative Siemens Healthineers solutions. As an alternative, customers who have an ADVIA Centaur system or an Atellica IM/CI may utilize the corresponding iPTH assay on those systems. These platforms are not impacted. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. A follow-up communication will be provided when assay performance has been restored. ***Update 2/18/2026*** On February 10, 2026 Follow-up Urgent Medical Device Correction letters were sent to additional customers to notify of the addition of new lots for the recall. Customer actions remained the same as the original letter.
Quantity in commerce: 3318 units (169 US, 3149 OUS)
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 Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Honduras, Hungary, India, Iran, Israel, Italy, Kosovo, Kuwait, Latvia, Lebanon, Macedonia, Mexico, Nepal, Netherlands, P.R. China, Pakistan, Palestinian Ter, Paraguay, Peru, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovakia, Slovenia, South Africa, Spain, Taiwan, Tunisia, Turkey, Turkmenistan, U.A.E., Ukraine, Uruguay, Uzbekistan.
Product codes and lots: 1. Siemens Material Number (SMN): 10381441; Catalog Number: L2KPP2; UDI-DI: 00630414961910; Lot Number: 385, ***Expanded 2/18/2026*** 387, 388, 389; 2. Siemens Material Number (SMN): 10381442; Catalog Number: L2KPP6; UDI-DI: 00630414961927; Lot Number: 385, ***Expanded 2/18/2026*** 387, 388, 389;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0366-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0366-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-05	2025-10-27

Product code CEW

K013566Class IIImmulite Intact Pth, Immulite 2000 Intact Pth, Models Lkpp1 (100 Tests), Lkpp5 (500 Tests), L2kpp2 (200 Tests), L2kpp6Diagnostic Products Corp. / cleared 2001-11-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)