Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
Check against the official notice below — it lists the full affected range.
Siemens Healthcare Diagnostics is recalling 149 kits of its Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit) because data submitted for Emergency Use Authorization was insufficient to determine that the assays were adequately validated for their intended use. The affected kits were distributed nationwide to Alaska, California, Colorado, Washington D.C., Georgia, Illinois, Maine, North Carolina, Nevada, New York, Oregon, Pennsylvania, Puerto Rico, Virginia, and the U.S. Virgin Islands.
Two lot numbers are affected by this recall: Lot #44989001 with an expiration date of October 7, 2021 (UDI # 00630414611846-44989001-20211007) and Lot #60407003 with an expiration date of March 22, 2021 (UDI # 00630414611846-60407003-20211112). The source document does not specify what action affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use.
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: 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 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.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.