FDA Device recall Z-0723-2017
ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD
- FDA Device
- Class II
- terminated
- Published 2016-12-14
On 2016-12-14 the FDA classified a Class II recall of ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD by Siemens Healthcare Diagnostics, citing 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 ADV….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0723-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-21 |
| Published | 2016-12-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | CA, CO, FL, IL, MI, NJ, NY, OH, PR, TX, WA, WI, WY |
Product
ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.
Reason
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.
Identifiers
| code_info | All serial numbers of ADVIA 560 Hematology Systems |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0723-2017%22
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