Parathyroid hormone assay recalled over falsely depressed results at low range
Siemens Healthcare Diagnostics is recalling 3,318 units of the IMMULITE 2000 Intact PTH assay over the potential for falsely depressed patient results at the low end of the assay range.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: falsely depressed results can misrepresent a patient's condition, and no injuries are reported.
Plain-English summary
The IMMULITE 2000 Intact PTH assay, test code iPT, Siemens material numbers 10381441 and 10381442, catalog numbers L2KPP2 and L2KPP6, is being recalled.
The firm identifies the potential for falsely depressed Intact PTH patient results at the low end of the assay range, at or below 50 pg/mL (5.3 pmol/L), when using specific lots on the IMMULITE 2000 and IMMULITE 2000 XPi systems. The bias is observed in both serum and plasma samples.
The recall covers 3,318 units, of which the record lists 169 in the United States and 3,149 outside it, distributed in Alabama, California, the District of Columbia, Florida, Idaho, Indiana, Louisiana, Maryland, North Carolina, New Jersey, New York, Pennsylvania and South Carolina, and internationally. The FDA has classified the action as Class II.
A falsely low result can misrepresent a patient's parathyroid status. Laboratories should identify affected lots and follow Siemens' instructions.
The recalled product
- Product
- Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6;
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- 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
Distribution
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