FDA Device recall Z-2482-2015
Contour Next Control Solution for Contour Next Blood Glucose Test System
- FDA Device
- Class II
- terminated
- Published 2015-09-09
On 2015-09-09 the FDA classified a Class II recall of Contour Next Control Solution for Contour Next Blood Glucose Test System by Bayer Healthcare, citing 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 contro….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2482-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-22 |
| Published | 2015-09-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Bayer Healthcare |
| Distribution | n/a |
Product
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.
Reason
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 glucose meter. Also, the control solution, used as a quality control test in blood glucose meter systems, may read outside the specified range too high or too low.
Identifiers
| code_info | SKU# 7314 (Level 2) and SKU# 7315 (Level 1) All Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2482-2015%22
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