Siemens Healthcare Diagnostics, Inc Recall 88768
Description: Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
Siemens Healthcare Diagnostics, Inc Recall 88768 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0195-2022 |
| Event ID | 88768 |
| Event Description | Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861 |
| 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 | 149 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 # 44989001 - Exp. Date 2021-10-07, UDI # (01)00630414611846(10)44989001(17)20211007; Lot # 60407003 - Exp. Date 2021-03-22, UDI # (01)00630414611846(10)60407003(17)20211112. |
| Center Classification Date | 20211103 |
| Recall Initiation Date | 20210922 |
| Recalling Firm | Siemens Healthcare Diagnostics, Inc |
| Initial Notification | Letter |
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