medical Class II Updated 2021-11-10

Siemens Healthcare Diagnostics, Inc recalls Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 1

Recalled Product

Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861


Hazard / Issue

Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/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.
View official government recall

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