Z-0195-2022 Class II Terminated
FDA device recall Z-0195-2022 was initiated by Siemens Healthcare Diagnostics, Inc on September 22, 2021 and is designated Class II. Reason for recall: Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use. The recall status is terminated (terminated August 2, 2022). Affected quantity: 149 kits.
Recall Details
- Product Type
- Devices
- Report Date
- November 10, 2021
- Initiation Date
- September 22, 2021
- Termination Date
- August 2, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 149 kits
Product Description
Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
Reason for Recall
Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use.
Distribution Pattern
US Nationwide distribution in the states of AK, CA, CO, DC, GA, IL, ME, NC, NV, NY, OR, PA, PR, VA and VI.
Code Information
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.