ADVIA 120 Hematology Analyzer — Class II medical device recall Z-2114-2013
Terminated recall by Siemens Healthcare Diagnostics, reported 2013-09-04, distributed nationwide. The ADVIA 120 optics cover or hood is located on the very top of the ADVIA 120 analyzer. When the optics cover
| Recall number | Z-2114-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Tarrytown, NY, United States |
| Recall initiated | 2013-06-26 |
| Classified | 2013-08-28 |
| Reported by FDA | 2013-09-04 |
| Terminated | 2017-02-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CH, CN, CZ, DE, DK, EG, ES, FI, FR, GB, GR, HR, HU, ID, IE, IL, IN, IQ, IS, IT, JP, KE, KR, KW, LB, LT, LU, MY, NL, NO, NZ, PH, PL, PT, RO, RS, SA, SE, SG, SI, SK, TH, TR, UA, VN, ZA |
| Model numbers | 10360958, 10360959 |
Product
ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . The ADVIA 120 is a hematology system that utilizes the principles of flow cytometry in order to provide complete blood counts.
Reason for recall
The ADVIA 120 optics cover or hood is located on the very top of the ADVIA 120 analyzer. When the optics cover is raised, it is supported by two gas struts (SMN 10309266) attached to the cover on the left and right sides. Over time, it is possible that these struts may lose their effectiveness and fail to support the optics cover in the open position. This could cause the cover to fall during maintenance procedures.
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-2114-2013. 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.