Siemens Healthcare recalls specific IMMULITE 2000 Thyroglobulin kits for potential inaccuracies in thyroid cancer monitoring tests. Users may see inconsistent results with low-level patient samples.
Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit lots; control level one may result outside of published ranges; when control results are in range, users may observe increased imprecision with low level patient samples
Siemens Healthcare is recalling certain IMMULITE 2000 Thyroglobulin kits that may not work correctly with some patient samples. This could lead to inaccurate thyroid cancer monitoring results if the kit is used without proper calibration.
The kit may produce results outside published ranges when used with control samples. When results are within range, low-level patient samples may show increased imprecision, potentially leading to inaccurate thyroid cancer monitoring.
Lab users who have the specific kit lots (D431, D433, D434, D435, D436) for the IMMULITE 2000 Systems Analyzers. Patients undergoing thyroid cancer monitoring are most at risk of inaccurate test results.
Check the kit lot number on the IMMULITE 2000 Thyroglobulin packaging. The affected lots are D431, D433, D434, D435, and D436. The product is sold with Siemens Healthcare's IMMULITE 2000 Systems Analyzers.
Look for the lot number on the IMMULITE 2000 Thyroglobulin packaging to determine if it is affected (D431, D433, D434, D435, or D436).
The kits may not meet instructions for use, causing control results to be outside published ranges and increased imprecision with low-level patient samples.
Lots D431, D433, D434, D435, and D436.
Check the lot number on the IMMULITE 2000 Thyroglobulin packaging; affected lots are D431, D433, D434, D435, and D436.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0949-2023 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0949-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
