IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 — Class II medical device recall Z-1886-2024
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2024-05-29, distributed nationwide. The potential for falsely elevated patient sample results when using impacted lots (782, 783, 785, 786, 787, 7
| Recall number | Z-1886-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., East Walpole, MA, United States |
| Recall initiated | 2024-04-23 |
| Classified | 2024-05-23 |
| Reported by FDA | 2024-05-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BD, BE, BG, BO, BR, CA, CL, CN, CO, CR, CY, CZ, DE, EC, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, IE, IL, IN, IR, IT, KR, LB, LT, LV, MX, MY, NL, NO, PE, PK, PL, PT, PY, RO, RS, RU, SA, SI, SK, TN, TR, TW, UA, UY, VN, ZA |
| UPC / GTIN / UDI-DI | 00630414962108 |
| Lot numbers | 782, 783, 786, 787, 788, 789, 791, 792, 793 |
| Model numbers | 10381659, L2KTG2 |
Product
IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System, Test, Thyroid Autoantibody.
Reason for recall
The potential for falsely elevated patient sample results when using impacted lots (782, 783, 785, 786, 787, 788, 789, 790, 791, 792 and 793), of IMMULITE 2000 Anti-TG Ab.
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-1886-2024. 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.