Drug recall
Ellume COVID-19 Home Test
FDA recall event 88801 · Class I · ELLUME LTD
Key facts
| Event ID | 88801 |
|---|---|
| Recall numbers | Z-0183-2022 |
| Recalling firm | ELLUME LTD |
| Product type | Devices |
| Products | Ellume COVID-19 Home Test |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to a higher rate of false positive test results. |
| Initiation date | Oct 1, 2021 |
| Report date | Nov 17, 2021 |
| City | East Brisbane |
| Country | Australia |
| FEI number | 3014862188 |
At a glance
- 1–9 Products in this recall
- None 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: