ADVIA Centaur Immunoassay System — Class II medical device recall Z-2715-2014
Terminated recall by Siemens Healthcare Diagnostics, reported 2014-10-08, distributed in GA. The firm has identified an issue with patient demographic information sent to the LIS from the ADVIA Centaur/A
| Recall number | Z-2715-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Tarrytown, NY, United States |
| Recall initiated | 2014-08-19 |
| Classified | 2014-09-29 |
| Reported by FDA | 2014-10-08 |
| Terminated | 2018-05-22 |
| Distributed | GA |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BH, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, EE, EG, ES, FI, FR, GB, HR, HU, ID, IE, IL, IN, IT, JO, JP, KR, LB, LT, LU, MT, MX, MY, NL, NO, NZ, PH, PK, PL, PT, QA, RO, RS, RU, SA, SG, SI, SK, TH, TR, VE, VN, ZA |
Product
ADVIA Centaur Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.
Reason for recall
The firm has identified an issue with patient demographic information sent to the LIS from the ADVIA Centaur/ADVIA Centaur XP Immunoassay systems. Siemens has confirmed that under extremely rare circumstances patient demographic data from the previous order received from the LIS is merged with the next order. This issue can occur when the LIS data buffer on the ADVIA Centaur system becomes full
Machine access
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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.