Product Wiki · Recalls · Health Canada — Medical Devices

CONTOUR NEXT CONTROL SOLUTION (2015-06-01) — recall 53809

Health Canada — Medical Devices · Canada · 2015-07-07 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
53809
Date of alert
2015-07-07
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: 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. 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/contour-next-control-solution-

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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