Drug recall
ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay…
FDA recall event 87146 · Class II · Beckman Coulter Inc.
Key facts
| Event ID | 87146 |
|---|---|
| Recall numbers | Z-0875-2021 |
| Recalling firm | Beckman Coulter Inc. |
| Product type | Devices |
| Products | ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Dec 30, 2020 |
| Report date | Jan 27, 2021 |
| Termination date | Sep 19, 2022 |
| City | Brea |
| State | CA |
| Country | United States |
| FEI number | 2050012 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: