FDA Device recall Z-1401-2021
ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
- FDA Device
- Class II
- ongoing
- Published 2021-04-21
On 2021-04-21 the FDA classified a Class II recall of ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11 by Siemens Healthcare Diagnostics, citing potential Sample Identification (SID) Mismatch with14-Character Barcodes.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1401-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-03-05 |
| Published | 2021-04-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Reason
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Identifiers
| code_info | Software Versions 6.10 and 6.11 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1401-2021%22
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