Device product
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
Z-2508-2021
Product summary
- Event
- Event 88612
- Status
- Terminated
- Classification
- Class II
- Quantity
- 303 kits (U.S.) and 964 kits (O.U.S.)
- Official record key
device-enforcement:Z-2508-2021
Official wording
Reason: Firm's submission for Emergency Use Authorization (EUA) contained insufficient evidence to be granted EUA Authorization to distribute
Code information: 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;
Distribution pattern: 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.
Derived failure modes
-
Unknown
Firm's submission for Emergency Use Authorization (EUA) contained insufficient evidence to be granted EUA Authorization to distribute