Bayer Healthcare, LLC recalls Contour Next Control Solution for Contour Next Blood Glucose Test System. Liquid quality control solution. Plastic bott…

Recall date

June 22, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2482-2015

FDA classification

Class II

Brand / firm

Bayer Healthcare, LLC

Sold / distributed

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…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.