Siemens Healthcare recalls specific IMMULITE 2000 Thyroglobulin kits for potential sensitivity problems that could lead to inaccurate test results. Affected kits may show inconsistent results with low 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 due to potential sensitivity issues that could cause inaccurate test results. This might lead to inconsistent results with low-level patient samples, which could affect thyroid cancer monitoring after surgery.
The kits may not function properly as described in the instructions, leading to test results outside expected ranges. When results are within range, low-level patient samples may show increased imprecision, potentially causing inaccurate thyroid cancer monitoring.
Lab users who purchased the specific kit lots (431-436) from Siemens Healthcare. Patients undergoing thyroid surgery monitoring are most at risk of inaccurate test results.
Check the kit lot numbers on the packaging. Affected lots are 431 through 436. The product is for in vitro diagnostic use with IMMULITE 2000 Systems Analyzers.
Look for lot numbers 431 through 436 on the IMMULITE 2000 Thyroglobulin kit packaging.
The kits may not meet the required sensitivity levels as stated in the instructions, potentially causing test results outside published ranges and inconsistent results with low-level patient samples.
Check the kit lot number on the packaging; affected lots are 431 through 436.
No, the recall does not require stopping use. The issue is about potential sensitivity, not immediate safety risks.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0950-2023 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0950-2023 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.
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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.
