ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866
Check against the official notice below — it lists the full affected range.
Siemens Healthcare Diagnostics, Inc. is recalling 261 ADVIA Centaur SARS-CoV-2 Antigen Assay test kits nationwide because data submitted for Emergency Use Authorization was insufficient to determine that the assays were adequately validated for their intended use. The recalled kits were distributed across 15 states and territories: Alaska, California, Colorado, the District of Columbia, Georgia, Illinois, Maine, North Carolina, Nevada, New York, Oregon, Pennsylvania, Puerto Rico, Virginia, and the Virgin Islands.
Two lots are affected by this recall: Lot #44990001 with expiration date October 7, 2021, and Lot #60408003 with expiration date November 12, 2021. The source document does not specify what action affected consumers should take regarding 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: 261 kits Lot/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.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.