Recall Z-0950-2023 · MSW System, Test, Thyroglobulin
Siemens Healthcare Diagnostics, Inc.
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
| Date | Jan 11, 2023 (initiated Dec 7, 2022) |
| Status | Open, Classified |
| 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 |
| Root cause | Under Investigation by firm |
| Action | Siemens Healthcare issued An Urgent Medical Device Correction (UMDC) to US affected customers by FedEx beginning 12/08/2022. An Urgent Field Safety Notice (UFSN) was issued to OUS Siemens reporting sites with affected customers, for distribution and regional reporting to their local competent authorities beginning on 12/07/2022. Letter states reason for recall, health risk and action to take: Discontinue use and discard Thyroglobulin kit lots listed in Table 1. Please review this letter with your Medical Director, including consideration for review of previously generated results as outlined |
| Quantity | 7,543 kits |
| Distribution | Nationwide Foreign: Argentina¿¿¿¿¿¿ Australia¿¿¿¿¿¿ Austria¿¿¿¿¿¿¿¿ Bahrain¿¿¿¿¿¿¿¿ Bangladesh¿¿¿¿¿ Belgium¿¿¿¿¿¿¿¿ Bolivia¿¿¿¿¿¿¿¿ Bosnia¿Herzeg.¿ Brazil¿¿¿¿¿¿¿¿¿ Bulgaria¿¿¿¿¿¿¿ Canada¿¿¿¿¿¿¿¿¿ Chile¿¿¿¿¿¿¿¿¿¿ Colombia¿¿¿¿¿¿¿ Costa¿Rica¿¿¿¿¿ Croatia¿¿¿¿¿¿¿¿ Cyprus¿¿¿¿¿¿¿¿¿ Czech¿Republic¿ Dominica |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982468 | IMMULITE 2000 THYROGLOBULIN MODEL L2KTY Diagnostic Products Corp., Mar 12, 1999 |