FDA-Device2015-09-09Class II
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.
Bayer Healthcare, LLC
Hazard
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.
Sold states
Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Croatia, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Slovenia, Spain, Sweden, Switzerland, UK, Albania, Azerbaijan, Bulgaria, Czech Republic, Estonia, Hungary, Korea, Latvia, Lithuania, Philippines, Romania, Serbia, Slovakia, and Thailand.
Affected count
5 million bottles of control solution
Manufactured in
430 S Beiger St, N/A, Mishawaka, IN, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2482-2015Don't want to check this manually?
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