FDA Device recall Z-0875-2021
ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only
- FDA Device
- Class II
- terminated
- Published 2021-01-27
On 2021-01-27 the FDA classified a Class II recall of ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only by Beckman Coulter, citing the Quality Control (QC) card has a label error for the standard deviation (SD) values for one out of the two levels of QC.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0875-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-12-30 |
| Published | 2021-01-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Beckman Coulter |
| Distribution | US |
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
The Quality Control (QC) card has a label error for the standard deviation (SD) values for one out of the two levels of QC.
Identifiers
| code_info | Catalog Number: C58964 UDI Code: 15099590738662 Lot Number: 922407 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0875-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.