FDAJune 22, 2015device

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 recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

bayer healthcarebayer

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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