ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to… — Class II medical device recall Z-0011-2014
Terminated recall by Siemens Healthcare Diagnostics, reported 2013-10-23, distributed nationwide. Siemens determined that if an autosampler rack jam error occurs during operation of an ADVIA 2120/2120i connec
| Recall number | Z-0011-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Tarrytown, NY, United States |
| Recall initiated | 2013-08-12 |
| Classified | 2013-10-17 |
| Reported by FDA | 2013-10-23 |
| Terminated | 2015-11-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, DE, DK, ES, FR, GB, GR, HR, IT, JP, KR, MY, NL, NO, PH, PT, SG, SI, TH, TR, VN |
| Reason classes | labeling |
Product
ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter) The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry in order to provide complete blood counts.
Reason for recall
Siemens determined that if an autosampler rack jam error occurs during operation of an ADVIA 2120/2120i connected to an ADVIA Autoslide, it is possible that the next slide processed by the Autoslide could be labeled with the wrong sample identification information.
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-0011-2014. 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.