Drug recall
IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs…
FDA recall event 62646 · Class II · AGFA Corp.
Key facts
| Event ID | 62646 |
|---|---|
| Recall numbers | Z-2184-2012 |
| Recalling firm | AGFA Corp. |
| Product type | Devices |
| Products | IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF) |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the final printed report. |
| Initiation date | Jul 27, 2012 |
| Report date | Aug 22, 2012 |
| Termination date | Jan 13, 2015 |
| City | Greenville |
| State | SC |
| Country | United States |
| FEI number | 3001236302 |
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: