Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK, REF C74339 A...
FDA Device Recall #Z-2508-2021 — Class II — August 5, 2021
Recall Summary
| Recall Number | Z-2508-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 5, 2021 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Beckman Coulter Inc. |
| Location | Brea, CA |
| Product Type | Devices |
| Quantity | 303 kits (U.S.) and 964 kits (O.U.S.) |
Product 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
Reason for Recall
Firm's submission for Emergency Use Authorization (EUA) contained insufficient evidence to be granted EUA Authorization to distribute
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.
Lot / 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;
Other Recalls from Beckman Coulter Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0541-2026 | Class II | DxFLEX Flow Cytometer Catalog Number C78500 UD... | Sep 22, 2025 |
| Z-0441-2026 | Class II | SYNCHRON Systems Direct LDL Cholesterol (LDLD) ... | Sep 17, 2025 |
| Z-0071-2026 | Class II | SYNCHRON Systems Phosphorus (PHOSm) Reagent RE... | Sep 3, 2025 |
| Z-2573-2025 | Class II | UniCel DxH 690T COULTER Cellular Analysis Syste... | Aug 13, 2025 |
| Z-2574-2025 | Class II | UniCel DxH 800 COULTER Cellular Analysis System... | Aug 13, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.