FDA Device recall Z-0949-2023
IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers (IMMULITE 2000/ IMMULITE 2000 XPi) f…
- FDA Device
- Class II
- ongoing
- Published 2023-01-18
On 2023-01-18 the FDA classified a Class II recall of IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers (IMMULITE 2000/ IMMULITE 2000 XPi) f… by Siemens Healthcare Diagnostics, citing 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 result….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0949-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-07 |
| Published | 2023-01-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
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
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
Identifiers
| code_info | UDI: 00630414972084 Kit Lots: D431, D433, D434, D435, and D436 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0949-2023%22
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