FDA Device recall Z-0196-2022
ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866
- FDA Device
- Class II
- terminated
- Published 2021-11-10
On 2021-11-10 the FDA classified a Class II recall of ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866 by Siemens Healthcare Diagnostics, citing data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0196-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-09-22 |
| Published | 2021-11-10 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866
Reason
Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use.
Identifiers
| code_info | Lot # 44990001, Exp. Date 2021-10-07, UDI # (01)00630414611747(10)44990001(17)20211007. Lot # 60408003, Exp. Date 202…Lot # 44990001, Exp. Date 2021-10-07, UDI # (01)00630414611747(10)44990001(17)20211007. Lot # 60408003, Exp. Date 2021-11-12, UDI # (01)00630414611747(10)60408003(17)20211112. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0196-2022%22
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