IMMULITE 2000 PTH Assay (Siemens) – result inaccuracy (2025)
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6;
Brand
Siemens Healthcare Diagnostics, Inc.
Lot Codes / Batch Numbers
1. Siemens Material Number (SMN): 10381441, Catalog Number: L2KPP2, UDI-DI: 00630414961910, Lot Number: 385, 2. Siemens Material Number (SMN): 10381442, Catalog Number: L2KPP6, UDI-DI: 00630414961927, Lot Number: 385
Products Sold
1. Siemens Material Number (SMN): 10381441; Catalog Number: L2KPP2; UDI-DI: 00630414961910; Lot Number: 385; 2. Siemens Material Number (SMN): 10381442; Catalog Number: L2KPP6; UDI-DI: 00630414961927; Lot Number: 385;
Siemens Healthcare Diagnostics, Inc. is recalling Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10 due to 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 t. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026