Beckman Coulter Inc. Recall 88612
Description: 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
Beckman Coulter Inc. Recall 88612 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2508-2021 |
| Event ID | 88612 |
| Event Description | 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 |
| Product Type | Devices |
| 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.) |
| Recall Reason | Firm's submission for Emergency Use Authorization (EUA) contained insufficient evidence to be granted EUA Authorization to distribute |
| Device Classification | 20210929 |
| Device 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; |
| Center Classification Date | 20210922 |
| Recall Initiation Date | 20210805 |
| Recalling Firm | Beckman Coulter Inc. |
| Initial Notification | Letter |
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