Access SARS-CoV-2 Antigen — Class II medical device recall Z-1670-2021
Terminated recall by Beckman Coulter Inc., reported 2021-06-02, distributed nationwide. specimens collected in transport media may result is false negative results when stored in certain conditions.
| Recall number | Z-1670-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2021-04-14 |
| Classified | 2021-05-21 |
| Reported by FDA | 2021-06-02 |
| Terminated | 2023-05-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | NZ |
| Quantity | 1,034 units |
| UPC / GTIN / UDI-DI | 15099590742713 |
| Model numbers | C68668 |
Product
Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL, R1d, 3.10 mL, R1e
Reason for recall
specimens collected in transport media may result is false negative results when stored in certain conditions.
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-1670-2021. 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.