IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi CEA — Class II medical device recall Z-1679-2018
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2018-05-16, distributed nationwide. Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for
| Recall number | Z-1679-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2018-01-02 |
| Classified | 2018-05-04 |
| Reported by FDA | 2018-05-16 |
| Terminated | 2023-02-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, MX, TH |
| Lot numbers | 0355, 0356, 0357CEA, 200 |
Product
IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi CEA
Reason for recall
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.
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-1679-2018. 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.