ADVIA 560 Hematology Systems — Class II medical device recall Z-1500-2016
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2016-04-27, distributed in CA, IL, PR, WA, WI. Software anomaly; Siemens identified that software version 1.4.2133 on the ADVIA 560 Hematology System does no
| Recall number | Z-1500-2016 |
|---|---|
| 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 | 2016-03-10 |
| Classified | 2016-04-20 |
| Reported by FDA | 2016-04-27 |
| Terminated | 2018-06-07 |
| Distributed | CA, IL, PR, WA, WI |
| Countries outside the US | AT, CA, CL, CO, CZ, DE, ES, FR, GB, IN, IT, KE, NL, NO, PT, SG, SI, TR |
| Reason classes | software |
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 for recall
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
Machine access
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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.