ADVIA Centaur Immunoassay System — Class II medical device recall Z-2662-2014
Terminated recall by Siemens Healthcare Diagnostics, reported 2014-09-24, distributed nationwide. The firm is conducting a field correction for the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems, rega
| Recall number | Z-2662-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Tarrytown, NY, United States |
| Recall initiated | 2014-08-13 |
| Classified | 2014-09-18 |
| Reported by FDA | 2014-09-24 |
| Terminated | 2017-05-02 |
| Distributed | Nationwide (US) |
| 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, Catalog Numbers/Siemens Material Numbers (SMN) 10284980, 10286140, 10309524, 10309525, 10310210, 10313282, 10314322, 10316248, 10316372, 10316968, 10317060, 10317403, 10319111, 10319433, 10320929, 10321568, 10322149, 10322731, 10323204, 10325015, 10326217, 10327008, 10327379, 10328250, 10328647, 10329364, 10330873, 10331013, 10332617, 10334139, 10334759, 10337512, 10337526, 10339677, 10340551, 10340737, 10341051, 10341110, 10361010, 10361011, 10361012 --- For in vitro diagnostic use This immunoassay system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use.
Reason for recall
The firm is conducting a field correction for the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems, regarding manually loaded sample racks that are improperly loaded or pushed too far on the sample entry queue during normal operation of the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems. Pushing the sample racks may cause misreads of Sample IDs (SID) if the sample rack loading instructions are not followed exactly as described in the ADVIA Centaur or ADVIA Centaur XP Operators Guide.
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.