CardioChek System - PTS Panels CHOL+HDL+GLU test strips (2019-04-11)

Starting date:

April 11, 2019

Posting date:

June 7, 2019

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-70101

Last updated: 2019-06-07

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  Reason
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  Affected products

Affected Products

CardioChek System - PTS Panels CHOL+HDL+GLU test strips

Reason

It has been determined that a triple-fault condition may cause a less-snug fit, or looseness of the strip within the guides on the analyzer. If the test strip "slips" from its fully inserted position, it may lead to the test not completing or an error code.

Affected products