Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 9, 2015
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.
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 contro…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Bayer Healthcare, LLC recalled Contour Next Control Solution for Contour Next Blood Glucose Test System. Liquid quality… - a moderate-severity action.
Contour Next Control Solution for Contour Next Blood Glucose Test System. Liquid quality… was recalled by Bayer Healthcare, LLC in September 9, 2015. Reason: If the control solution bottle is not thoroughly shaken prior to use, the control test result may be higher t…. Check the official notice for the remedy. Verify recall #Z-2482-2015 with the FDA Devices before acting.
The recall
Bayer Healthcare, LLC issued this moderate-severity FDA Devices recall-If the control solution bottle is not thoroughly shaken prior to use, the control test result may be higher t….
- Moderate
- severity level
- Class II
- classification
- September 9, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2482-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2482-2015) was formally reported on September 9, 2015, with the manufacturer initiating the action on June 22, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Bayer Healthcare, LLC is listed as the recalling firm, operating out of Mishawaka, IN. Federal records list the affected scope as 5 million bottles of control solution.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Croatia, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Slovenia, Spain, Sweden, Switzerland, UK…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
5 million bottles of control solution
Related Recalls
6
3 from same agency
Product description
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.
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2482-2015 |
| Date reported | September 9, 2015 |
| Date initiated | June 22, 2015 |
| Recalling firm | Bayer Healthcare, LLC |
| Firm location | Mishawaka, IN |
| Affected scope | 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, Azerbaija… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2482-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product 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.. Recalled by Bayer Healthcare, LLC. Units affected: 5 million bottles of control solution.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 9, 2015. Severity: Moderate. Recall number: Z-2482-2015.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2482-2015) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 9, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.