Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK, REF C74339 Access SARS-CoV-2 IgG (1st IS) Calibrators, REF C74340 Access SARS-CoV-2 (1st IS) Quality Control (QC), REF C74341
Check against the official notice below — it lists the full affected range.
Beckman Coulter Inc. is recalling Access SARS-CoV-2 IgG assay kits and related calibrators and quality control materials because the company's submission for Emergency Use Authorization contained insufficient evidence to support authorization for distribution. The affected products include reagent packs (Part Number C74339), calibrators (Part Number C74340), and quality control materials (Part Number C74341) with specific lot numbers identified in the recall notice.
The recall affects 303 kits distributed in the United States across Arizona, California, Georgia, Illinois, Iowa, Kentucky, Michigan, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, Virginia, Washington, and Puerto Rico, as well as 964 kits distributed outside the United States. The source document does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Firm's submission for Emergency Use Authorization (EUA) contained insufficient evidence to be granted EUA Authorization to distribute
Reason for recall: Firm's submission for Emergency Use Authorization (EUA) contained insufficient evidence to be granted EUA Authorization to distribute Distribution: U.S. Nationwide distribution in the states of AZ, CA, GA, IL, IA, KY, MI, NJ, NY, NC, OH, PA, Puerto Rico, TN, TX, VA, and WA. Quantity: 303 kits (U.S.) and 964 kits (O.U.S.) Lot/code info: Part Number: C74339 UDI Code: (01)15099590746919(17)210930(11)210402(10)124466 Lot Number: 124466; Part Number: C74340 UDI Codes: (01)15099590746926(17)210930(11)210402(10)124467; (01)15099590746926(17)211231(11)210703(10)124758; Lot Numbers: 124467; 124758; Part Number: C74341 UDI Codes: (01)15099590746933(17)210930(11)210402(10)124468; (01)15099590746933(17)211130(11)210602(10)124708; Lot Numbers: 124468; 124708;
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.