ADVIA 2120 REFURB SAA AUTOSAMPLER — Class II medical device recall Z-1398-2021
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2021-04-21, distributed nationwide. Potential Sample Identification (SID) Mismatch with14-Character Barcodes
| Recall number | Z-1398-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2021-03-05 |
| Classified | 2021-04-09 |
| Reported by FDA | 2021-04-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DZ, EC, EG, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KE, KR, KW, LB, LT, LU, MT, MX, MY, NL, NO, OM, PE, PH, PK, PL, PT, QA, RO, RS, SA, SE, SG, SI, SK, TH, TR, TT, TW, UA, UY, VN, ZA |
| Quantity | 195 units |
Product
ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Reason for recall
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
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-1398-2021. 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.