Access SARS-CoV-2 Antigen Calibrators — Class II medical device recall Z-2256-2021
Terminated recall by Beckman Coulter Inc., reported 2021-08-18, distributed nationwide. SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .
| Recall number | Z-2256-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2021-07-01 |
| Classified | 2021-08-12 |
| Reported by FDA | 2021-08-18 |
| Terminated | 2023-06-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | NZ |
| Quantity | 451 units |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 15099590742720 |
| Model numbers | C68669 |
Product
Access SARS-CoV-2 Antigen Calibrators, Catalog, REF: C68669, Contents: 1x2.5 mL C0, 1x2.5mL C1, 1x CAL CARD, UDI: (01)15099590742720;
Reason for recall
SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .
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-2256-2021. 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.