Siemens Healthcare Diagnostics, Inc Recall 88768
Description: ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866
Siemens Healthcare Diagnostics, Inc Recall 88768 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0196-2022 |
| Event ID | 88768 |
| Event Description | ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of AK, CA, CO, DC, GA, IL, ME, NC, NV, NY, OR, PA, PR, VA and VI. |
| Quantity | 261 kits |
| Recall Reason | Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use. |
| Device Classification | 20211110 |
| Device Code Info | 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. |
| Center Classification Date | 20211103 |
| Recall Initiation Date | 20210922 |
| Recalling Firm | Siemens Healthcare Diagnostics, Inc |
| Initial Notification | Letter |
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