Drug recall
Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument…
FDA recall event 83402 · Class II · Phadia Ab
Key facts
| Event ID | 83402 |
|---|---|
| Recall numbers | Z-2397-2019 |
| Recalling firm | Phadia Ab |
| Product type | Devices |
| Products | Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including software for immunodiagnostic testing. The instrument is designed to handle all… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | code 7-102 Liquid Sensor Error |
| Initiation date | Jul 9, 2019 |
| Report date | Sep 4, 2019 |
| Termination date | Jul 12, 2022 |
| City | Uppsala |
| Country | Sweden |
| FEI number | 3002807876 |
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: