ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 — Class II medical device recall Z-0875-2021
Terminated recall by Beckman Coulter Inc., reported 2021-01-27, distributed nationwide. The Quality Control (QC) card has a label error for the standard deviation (SD) values for one out of the two
| Recall number | Z-0875-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2020-12-30 |
| Classified | 2021-01-15 |
| Reported by FDA | 2021-01-27 |
| Terminated | 2022-09-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, BG, BR, CA, DE, ES, FR, GB, HK, HR, IT, JO, MX, PL, PT, PY, RO |
| Quantity | 276 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 15099590738662 |
| Lot numbers | 922407 |
| Model numbers | C58964 |
Product
ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only.
Reason for recall
The Quality Control (QC) card has a label error for the standard deviation (SD) values for one out of the two levels of QC.
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-0875-2021. 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.