Drug recall
Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be used with Cassette-based…
FDA recall event 79271 · Class II · Quidel Corporation
Key facts
| Event ID | 79271 |
|---|---|
| Recall numbers | Z-1183-2018 |
| Recalling firm | Quidel Corporation |
| Product type | Devices |
| Products | Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be used with Cassette-based immunofluorescent in vitro diagnostic assays . Sofia 2 is intended for professional and… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The calibration for the affected batch of analyzers was incorrectly set during the manufacturing process which may lead to a failure when calibration is first performed. There may also be e remote… |
| Initiation date | Dec 15, 2017 |
| Report date | Apr 4, 2018 |
| Termination date | Oct 21, 2019 |
| City | San Diego |
| State | CA |
| Country | United States |
| FEI number | 2024674 |
At a glance
- 1–9 Products in this recall
- 1–9 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: