ADVIA 560 Hematology Systems — Class II medical device recall Z-0723-2017
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2016-12-14, distributed in CA, CO, FL, IL, MI, NJ, NY, OH…. Siemens is investigating an issue which may cause an incorrect result to be reported. Siemens received two rep
| Recall number | Z-0723-2017 |
|---|---|
| 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 | 2016-10-21 |
| Classified | 2016-12-08 |
| Reported by FDA | 2016-12-14 |
| Terminated | 2018-06-07 |
| Distributed | CA, CO, FL, IL, MI, NJ, NY, OH, PR, TX, WA, WI, WY |
| Countries outside the US | AU, BE, BR, CA, CH, CL, CO, CZ, DE, EG, ES, FR, GB, GR, HR, IN, IT, JP, KE, MX, MY, NL, NO, PK, PT, SA, SI, TR, VN |
Product
ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.
Reason for recall
Siemens is investigating an issue which may cause an incorrect result to be reported. Siemens received two reports of multiple discordant records for the same Sample ID in the ADVIA 560 Hematology System database that occurred during the installation of the systems. The database should only contain one record of a Sample ID number for any given time and date. If there are multiple records for the same Sample ID, it is possible that multiple results may be manually or automatically sent to the Laboratory Information System (LIS), printed or displayed on the results report screen.
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-0723-2017. 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.