ADVIA Centaur XP Immunoassay System — Class II medical device recall Z-0860-2015
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2014-12-31, distributed nationwide. A slight crack of the tubing at the connecting fitting on the reservoir connector assembly may occur due to me
| Recall number | Z-0860-2015 |
|---|---|
| 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 | 2014-10-09 |
| Classified | 2014-12-23 |
| Reported by FDA | 2014-12-31 |
| Terminated | 2017-03-16 |
| Distributed | Nationwide (US) |
| Quantity | 10,515 units |
| Reason classes | packaging |
Product
ADVIA Centaur XP Immunoassay System (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.
Reason for recall
A slight crack of the tubing at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress.
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-0860-2015. 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.