Z-2482-2015Class II

Contour Next Control Solution for Contour Next Blood Glucose Test System. Liquid quality control solution...

Name: Z-2482-2015 Contour Next Control Solution for Contour Next Blood Glucose Test System. Liquid quality control solution...
Creator: Bayer Healthcare, LLC
Published: 2015-06-22
License: https://open.fda.gov/license/

Medrad, Inc. / initiated 2015-06-22 / Terminated / root cause: design

FDA source

Bayer Healthcare, LLC began a recall of Contour Next Control Solution for Contour Next Blood Glucose Test System. Liquid quality control solution. Plastic bottle, 2.5mL. Indicated for use with fresh... on 2015-06-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2482-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-22
Posted: 2015-08-29
Terminated: 2016-05-23
Recalling firm: Medrad, Inc.
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.
Product code: JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
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.
Root cause tag: design
FDA root cause: Device Design
Action: On 6/22/2015, Bayer Healthcare began sending URGENT - MEDICAL DEVICE FIELD CORRECTIVE ACTION notifications to affected Health Care Providers, Pharmacies, and Users. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers are instructed to always check the expiration, not to use and discard of expired control solutions. Also, only CONTOUR NEXT control solution should be used with the CONTOUR NEXT test strips. The control solution bottle should be shaken about 15 times before each use. The letter instructed customers to refer to their meter's user guide for further testing instructions. If test results outside the control range are received, another test should be performed following the instructions provided in the letter. If the problem persists, customers should contact Bayer Diabetes Support. Bayer will replace the control solution or provide new control ranges for the test strips, depending on the situation. The firm has implemented improvements to provide more consistent control solution product.
Quantity in commerce: 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.
Product codes and lots: SKU# 7314 (Level 2) and SKU# 7315 (Level 1) All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2482-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2482-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-08-28

Product code JJX

K111268Class IIContour (R) Next Blood Glucose Monitoring SystemBayer Healthcare / cleared 2012-03-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)