Access SARS CoV-2 IgG — Class II medical device recall Z-2508-2021
Terminated recall by Beckman Coulter Inc., reported 2021-09-29, distributed nationwide. Firm's submission for Emergency Use Authorization (EUA) contained insufficient evidence to be granted EUA Auth
| Recall number | Z-2508-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2021-08-05 |
| Classified | 2021-09-22 |
| Reported by FDA | 2021-09-29 |
| Terminated | 2023-06-01 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 15099590746919, 15099590746926, 15099590746933 |
| Lot numbers | 124466, 124467, 124468, 124708, 124758 |
| Model numbers | C74339, C74340, C74341 |
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
Reason for recall
Firm's submission for Emergency Use Authorization (EUA) contained insufficient evidence to be granted EUA Authorization to distribute
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2508-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.