Drug recall
LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome…
FDA recall event 87259 · Class II · LumiraDx
Key facts
| Event ID | 87259 |
|---|---|
| Recall numbers | Z-1132-2021 |
| Recalling firm | LumiraDx |
| Product type | Devices |
| Products | LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 Antigen (Ag) Test Strips, Catalog #:L016000109048. Part of the LumiraDx Platform… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Observations of potential false positive results in the specified lots. Use of these test strips may result in false positive patient test results and potential exposure to unnecessary treatment or… |
| Initiation date | Jan 11, 2021 |
| Report date | Feb 24, 2021 |
| Termination date | Dec 3, 2021 |
| City | Waltham |
| State | MA |
| Country | United States |
| FEI number | 3012642695 |
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: