Lower riskMedical device recall · FDA · Published December 7, 2022
Siemens IMMULITE 2000 Thyroglobulin Kit May Not Work Properly in Some Tests
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 IMMULITE 2000 Thyroglobulin Kit May Not Work Properly in Some Tests.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59198-siemens-immulite-2000-thyroglobulin-kit-may-not-work-properly-in. Based on FDA recall #Z-0949-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0949-2023%22&limit=1).
The FDA announced on 2022-12-07 that Siemens Healthcare Diagnostics, Inc. is recalling IMMULITE 2000 Thyroglobulin (US) in vitro diagnostic kits due to potential functional sensitivity issues. The agency issued recall number Z-0949-2023 for the voluntary Class II action affecting 717 kits distributed nationwide and internationally.
How to tell if you have it
Brand: Siemens Healthcare
Product: IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers
Catalog #: L2KTY2(D)
Siemens Material Number: 10381647
UDI: 00630414972084
Kit Lots: D431, D433, D434, D435, and D436
The hazard
The recall addresses the potential for functional sensitivity to not meet Instructions For Use claims. Control level one may result outside of published ranges, and users may observe increased imprecision with low level patient samples when control results are in range.
Context
GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has had 150 other recalls on record since 2017-06-07. Recent brand-specific actions include the 2026-08-17 recall of Siemens Atellica CH RCRP Test for falsely elevated results and the 2026-07-06 recall of Siemens Atellica CH Urine Albumin for false results risk. Other recent recalls of similar products include the 2025-11-21 Roche Elecsys Anti-TSHR Assay Recall, the 2026-03-16 Beckman Coulter Access Total T4 Calibrator Recall, and the 2025-11-03 GET TESTED Thyroid TSH Test Recall.
How to tell if you have this one
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.
Brand
Siemens Healthcare
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers (IMMULITE 2000/ IMMULITE 2000 XPi) for the quantitative measurement of thyroglobulin in serum or heparinized plasma, as an aid in monitoring patients who have undergone thyroidectomy. Catalog # L2KTY2(D) Siemens Material Number (SMN): 10381647; UDI: 00630414972084 Kit Lots: D431, D433, D434, D435, and D436
717 kits
Z-0950-2023
IMMULITE 2000 Thyroglobulin (OUS). For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of thyroglobulin in serum or heparinized plasma, as an aid in monitoring patients who have undergone thyroidectomy. Catalog # Catalog # L2KTY2 Siemens Material Number (SMN): 10381648; UDI: 00630414962252 Kit Lots: 431, 432, 433, 434, 435, and 436.
7,543 kits
Based on the official FDA remedy
What to do — step by step
Check Kit Lot Number
Look for the lot number on the IMMULITE 2000 Thyroglobulin packaging to determine if it is affected (D431, D433, D434, D435, or D436).
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Nationwide Foreign: Argentina¿¿¿¿¿¿ Australia¿¿¿¿¿¿ Austria¿¿¿¿¿¿¿¿ Bahrain¿¿¿¿¿¿¿¿ Bangladesh¿¿¿¿¿ Belgium¿¿¿¿¿¿¿¿ Bolivia¿¿¿¿¿¿¿¿ Bosnia¿Herzeg.¿ Brazil¿¿¿¿¿¿¿¿¿ Bulgaria¿¿¿¿¿¿¿ Canada¿¿¿¿¿¿¿¿¿ Chile¿¿¿¿¿¿¿¿¿¿ Colombia¿¿¿¿¿¿¿…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 42 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0949-2023 (December 7, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0949-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.