Siemens Healthcare recalls specific lots of IMMULITE 2000 Intact PTH tests that may produce falsely low PTH results, affecting patient diagnosis. Check your test lot numbers to see if affected.
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.
Siemens Healthcare is recalling specific lots of IMMULITE 2000 Intact PTH tests that can give falsely low results for patients with low PTH levels. This could lead to incorrect diagnoses if the test is used without knowing the problem.
The test may show lower than actual PTH levels in patients with low PTH, especially when results are below 50 pg/mL. This could cause doctors to miss important health issues that need treatment.
Patients using the IMMULITE 2000 Intact PTH test (test code iPT) with specific lot numbers. Those with low PTH levels may be at risk of incorrect diagnosis.
Check the lot number on your test kit. Affected lots are 385, 387, 388, and 389 for both material numbers 10381441 and 10381442. These were sold with catalog numbers L2KPP2 and L2KPP6.
Look for the lot number on your IMMULITE 2000 Intact PTH test kit. Affected lots are 385, 387, 388, and 389.
The test may show falsely low PTH levels for patients with low PTH, especially when results are below 50 pg/mL.
Affected lots are 385, 387, 388, and 389 for both material numbers 10381441 and 10381442.
Check the lot number on your test kit. If it's 385, 387, 388, or 389, it's affected.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0366-2026 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0366-2026 from Siemens Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
