FDA Device recall Z-1500-2016
ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD The ADVIA 560 Hematology System is a fully-automated, high-qualit…
- FDA Device
- Class II
- terminated
- Published 2016-04-27
On 2016-04-27 the FDA classified a Class II recall of ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD The ADVIA 560 Hematology System is a fully-automated, high-qualit… by Siemens Healthcare Diagnostics, citing software anomaly; Siemens identified that software version 1.4.2133 on the ADVIA 560 Hematology System does not trigger the following flags: The G or L morphology flags for immatu….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1500-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-10 |
| Published | 2016-04-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | CA, IL, PR, WA, WI |
Product
ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD The ADVIA 560 Hematology System is a fully-automated, high-quality hematology system for in vitro diagnostic use in clinical laboratories
Reason
Software anomaly; Siemens identified that software version 1.4.2133 on the ADVIA 560 Hematology System does not trigger the following flags: The G or L morphology flags for immature granulocytes (IG) and atypical lymphocytes (ATYP), respectively. The results from patient samples which have immature granulocytes or atypical lymphocytes will not generate the flags when they should. As defined in t
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-1500-2016%22
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