Drug recall
Contour Next Control Solution for Contour Next Blood Glucose Test System. Liquid quality control solution…
FDA recall event 71611 · Class II · Bayer Healthcare, LLC
Key facts
| Event ID | 71611 |
|---|---|
| Recall numbers | Z-2482-2015 |
| Recalling firm | Bayer Healthcare, LLC |
| Product type | Devices |
| Products | Contour Next Control Solution for Contour Next Blood Glucose Test System. Liquid quality control solution. Plastic bottle, 2.5mL. Indicated for use with fresh fingertip capillary whole blood samples. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | If the control solution bottle is not thoroughly shaken prior to use, the control test result may be higher than the control range and may not be recognized and marked as a control test by the blood… |
| Initiation date | Jun 22, 2015 |
| Report date | Sep 9, 2015 |
| Termination date | May 23, 2016 |
| City | Mishawaka |
| State | IN |
| Country | United States |
| FEI number | 1826988 |
At a glance
- 1–9 Products in this recall
- 10–99 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: