Bayer Recalls Contour Next Control Solution for Potential Test Errors
Bayer is recalling 5 million bottles of Contour Next Control Solution because improper shaking may cause inaccurate blood glucose meter readings.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a functional defect in a quality control solution that may lead to inaccurate meter readings rather than a direct physical injury or high-risk pathogen exposure, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Bayer Healthcare, LLC is recalling 5 million bottles of Contour Next Control Solution for the Contour Next Blood Glucose Test System. The product is a liquid quality control solution in a 2.5mL plastic bottle, indicated for use with fresh fingertip capillary whole blood samples. The recall includes all lots of SKU# 7314 (Level 2) and SKU# 7315 (Level 1).
The recall was initiated because 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. Additionally, the control solution may read outside the specified range, either too high or too low.
The affected products were distributed worldwide, including in the 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. Consumers should stop using the product and contact Bayer for instructions on return or replacement.
The recalled product
- Product
- 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.
- Manufacturer
- Bayer Healthcare, LLC
- Hazard
- Affected units
- 5
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- SKU# 7314 (Level 2) and SKU# 7315 (Level 1) All Lots
Distribution
Distribution scope not specified by the agency.
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