Recall Z-2482-2015— Bayer Healthcare, LLC
Class II · Terminated
Class II FDA medical device recall by Bayer Healthcare, LLC, initiated 2015-06-22, terminated 2016-05-23. It names one FDA 510(k) clearance: K111268. 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..
- Recalling firm
- Bayer Healthcare, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-06-22
- Terminated
- 2016-05-23
- Firm location
- Mishawaka, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 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 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.