IMMULITE 2000 Thyroglobulin — Class II medical device recall Z-0949-2023
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2023-01-18, distributed nationwide. Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit lots; control
| Recall number | Z-0949-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2022-12-07 |
| Classified | 2023-01-11 |
| Reported by FDA | 2023-01-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CY, CZ, DE, EC, EE, EG, ES, FI, FR, GR, HN, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JO, KR, LT, LV, MA, MX, MY, NL, NP, PA, PE, PH, PK, PL, PT, PY, RO, RS, SE, SG, SI, SK, TN, TR, TT, TW, UA, UY, VN |
| Quantity | 717 kits |
| UPC / GTIN / UDI-DI | 00630414972084 |
| Lot numbers | D431, D433, D434, D435, D436 |
| Model numbers | L2KTY2 |
Product
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
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0949-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.