—#216317

Product

Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6;

FDA product code: CEW — Radioimmunoassay, Parathyroid Hormone
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K013566
Affected lot / code info: 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;

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 333 Coney St, East Walpole, Massachusetts 02032-1516

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2025-09-22
Posted by FDA: 2025-10-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #216317. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.