Contour Next Control Solution for Contour Next Blood recall
Contour Next Control Solution for Contour Next Blood Glucose Test System. Liquid quality control solution. Plastic bottle, 2.5mL. Indicated for use…
Why was Contour Next Control Solution for Contour Next Blood 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
SKU# 7314 (Level 2) and SKU# 7315 (Level 1) All Lots
- Product
- Contour Next Control Solution for Contour Next Blood Glucose Test System. Liquid quality control solution. Plastic bottle, 2.5mL. Indicated for use…
- Recalling firm
- Bayer Healthcare, LLC
- Quantity
- 5 million bottles of control solution
- Distribution
- 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.
- Recall date
- September 9, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)