ADVIA¿ Centaur XPT system software versions V1 — Class II medical device recall Z-2256-2016
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2016-07-27, distributed nationwide. Eight (8) issues were identified which may affect the results generated by the system software version.
| Recall number | Z-2256-2016 |
|---|---|
| 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 | 2016-05-26 |
| Classified | 2016-07-21 |
| Reported by FDA | 2016-07-27 |
| Terminated | 2018-06-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BD, BE, CA, CH, CL, CN, CZ, DE, DK, EG, ES, FI, FR, GB, HK, HU, IE, IN, IT, JO, JP, KR, LV, MY, NL, NO, NZ, PH, PL, PT, QA, SA, SE, SG, SK, TR, VN |
| Reason classes | software |
Product
ADVIA¿ Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN 11219806), V1.0.3 (Bundle 1.0.1108 SMN 11220781) and V1.1 (Bundle 1.1.243 SMN 11221979). Product Usage: 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
Eight (8) issues were identified which may affect the results generated by the system software version.
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-2256-2016. 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.