ADVIA Centaur BNP — Class II medical device recall Z-2053-2018
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2018-06-13, distributed in AL, CA, DE, GA, IA, IL, IN, KY…. In certain scenarios the ADVIA Centaur CP, XP and XPT immunoassay analyzers may exhibit reduced dilution recov
| Recall number | Z-2053-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2017-12-18 |
| Classified | 2018-06-01 |
| Reported by FDA | 2018-06-13 |
| Distributed | AL, CA, DE, GA, IA, IL, IN, KY, MA, MI, MS, MT, NC, ND, NJ, NM, NV, NY, OH, PA, PR, RI, TN, TX, VA, WA, WV, WY |
| Countries outside the US | AE, AU, BE, CA, CH, CL, DE, ES, FR, GR, IL, IT, JP, LU, LV, NL, NO, NZ, PL, PT, RO, SG, SK, ZA |
| Quantity | 21,687 |
| Model numbers | 02816138 |
Product
ADVIA Centaur BNP (B-type Natriuretic Peptide), Catalog Numbers: 02816138 (100 tests), 02816634 (500 tests)
Reason for recall
In certain scenarios the ADVIA Centaur CP, XP and XPT immunoassay analyzers may exhibit reduced dilution recovery or become inoperable when used with Multi-Diluent 15 and certain lots of BNP and TSH3RUL Assays.
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-2053-2018. 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.