Bayer Healthcare, LLC: Medical Device Recall in 2015 - (Recall #: Z-2482-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: June 22, 2015

Date Posted: September 9, 2015

Recall Number: Z-2482-2015

Event ID: 71611

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.

Status: Terminated

Product Quantity: 5 million bottles of control solution

Code Information:

SKU# 7314 (Level 2) and SKU# 7315 (Level 1) All Lots

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated