IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating… — Class II medical device recall Z-1820-2022
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2022-10-05, distributed nationwide. An average negative bias of -23% with IMMULITE 2000/IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI
| Recall number | Z-1820-2022 |
|---|---|
| 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 | 2022-08-11 |
| Classified | 2022-09-27 |
| Reported by FDA | 2022-10-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BR, CN, CZ, DE, ES, IT, SG, TN, TR, TW |
| UPC / GTIN / UDI-DI | 00630414597171, 00630414597188 |
| Lot numbers | 389 |
| Expiration dates | 2022-11-30 |
Product
IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) Siemens Material Number (SMN): 10876421 US; 10713448 (OUS)
Reason for recall
An average negative bias of -23% with IMMULITE 2000/IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) when compared to other in-date kit lots, there is a potential for erroneously depressed patient results. This may lead to a delayed follow up of patients with clinical autoimmune thyroid
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-1820-2022. 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.