Reported Sep 9, 2015 · Terminated
Contour Next Control Solution for Contour Next Blood Glucose Test System. Liquid quality control solution. Plastic…
Bayer Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bayer Healthcare, LLC · 430 S Beiger St · Mishawaka, IN · 46544-3207
Is this the product you have?
- 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.
- Lot codes and dates
- SKU# 7314 (Level 2) and SKU# 7315 (Level 1) All Lots
- Amount recalled
- 5 million bottles of control solution
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.
This product could cause temporary or reversible health problems — stop using it.
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