IMMULITE 2000 Systems IPT Intact PTH recallZ-0366-2026 · Siemens Healthcare Diagnostics, Inc. · initiated Sep 22, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-0366-2026
- Status
- Open, Classified
- Initiated by the company
- Sep 22, 2025
- Posted by the FDA
- Oct 27, 2025
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 3318 units (169 US, 3149 OUS)
- Product code
- CEW
- FDA submissions
- K013566
- 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 description
Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6;
Code information (models, lots, serial numbers)
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;
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- IMMULITE® 2000 Systems IPT Intact PTH 10381441Siemens Healthcare Diagnostics Products Ltd · RADIOIMMUNOASSAY, PARATHYROID HORMONE1 recall18 reports
- IMMULITE® 2000 Systems IPT Intact PTH 10381442Siemens Healthcare Diagnostics Products Ltd · RADIOIMMUNOASSAY, PARATHYROID HORMONE1 recall0 reports
Product lines
Other devices under the same FDA submission
2 devices cleared under K013566 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- IMMULITE® Systems PTH CONTROL Intact PTH 10385354Siemens Healthcare Diagnostics Products Ltd · RADIOIMMUNOASSAY, PARATHYROID HORMONE1 report
- IMMULITE®/IMMULITE® 1000 Systems iPT Intact PTH 10381399Siemens Healthcare Diagnostics Products Ltd · RADIOIMMUNOASSAY, PARATHYROID HORMONE1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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