CONTOUR NEXT CONTROL SOLUTION (2015-06-01)

Starting date:

June 1, 2015

Posting date:

July 7, 2015

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-53982

• Reason
• Affected products

Recalled Products

1. CONTOUR NEXT CONTROL SOLUTION (NORMAL)
2. CONTOUR NEXT CONTROL SOLUTION (HIGH)
3. CONTOUR NEXT CONTROL SOLUTION (LOW)

Reason

1. Control result not marked as a control test: Bayer Healthcare has received user reports on CONTOUR NEXT control test results that are higher than the control range published on the packaging of contour next test strips and not recognized as control tests by the meter.  All lots of CONTOUR NEXT control solution (levels low, normal and high) are affected.
2. Control result outside of control range:  Another issue may affect any control solution lots when used with of CONTOUR NEXT test strip lots with expiration dates through November 2016.  Due to unforeseen material variation, lots of contour next control solution may give control test results that are outside of the assigned control range as published on the packaging of CONTOUR NEXT test strips.  These control results are properly marked as control tests by the meter therefore this issue does not impact insulin pumps.

Affected products