Drug recall
Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for in vitro diagnostic use as a…
FDA recall event 67724 · Class II · Clinical Diagnostic Solutions
Key facts
| Event ID | 67724 |
|---|---|
| Recall numbers | Z-1436-2014 |
| Recalling firm | Clinical Diagnostic Solutions |
| Product type | Devices |
| Products | Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots. |
| Initiation date | Feb 24, 2013 |
| Report date | Apr 16, 2014 |
| Termination date | Aug 7, 2014 |
| City | Plantation |
| State | FL |
| Country | United States |
| FEI number | 3002684533 |
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: