ADVIA Centaur XPT System Software Versions V1 — Class II medical device recall Z-1537-2017
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2017-03-29, distributed in CA, GA, IL, MD, MN, MS, NH, TX…. Multiple software issues, which may affect the operation and workflow of the system. Potential for an apparent
| Recall number | Z-1537-2017 |
|---|---|
| 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 | 2017-02-02 |
| Classified | 2017-03-23 |
| Reported by FDA | 2017-03-29 |
| Terminated | 2018-06-22 |
| Distributed | CA, GA, IL, MD, MN, MS, NH, TX, WA |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EG, ES, FI, FR, GB, GR, HU, ID, IE, IN, IR, IT, JO, JP, KR, LV, MY, NL, NO, NZ, PE, PH, PL, PT, QA, RS, SA, SE, SG, SK, TR, UY, VN |
| Reason classes | software |
Product
ADVIA Centaur XPT System Software Versions V1.0.1, V1.0.2, V1.0.3, V1.1 and V1.2. The ADVIA Centaur XPT System is a stand-alone, continuous operation, immunochemistry analyzer that performs the following functions: aspirates and dispenses samples; Performs dilutions; Adds reagents; Incubates reaction vessels; Separates solid and liquid wastes; Measures photon emissions; Performs data reduction; Collects and maintains patient demographics and results.
Reason for recall
Multiple software issues, which may affect the operation and workflow of the system. Potential for an apparent delay to testing when these issues occur. The software issues affecting the analyzer may impact all analytes available on the ADVIA Centaur XPT System test menu.
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-1537-2017. 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.