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Contour Next Control Solution for Contour Next Blood… recallZ-2482-2015 · Bayer Healthcare, LLC · initiated Jun 22, 2015

Class II Terminated All recalls posted in August 2015

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Bayer Healthcare, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-2482-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Jun 22, 2015
Posted by the FDA
Aug 29, 2015
Recalling firm
Bayer Healthcare, LLC
Quantity
5 million bottles of control solution
Product code
JJX
FDA submissions
K111268
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 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.

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

3 devices cleared under K111268 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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