CardioChek System - PTS Panels (Cholesterol Test Strips, CHOL+HDL+GLU Test Strips) (2019-03-26)

Starting date:

March 26, 2019

Posting date:

April 18, 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-69624

Last updated: 2019-04-18

• Reason
• Affected products

Affected Products

1. CardioChek System - PTS Panels Cholesterol Test Strips
2. 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. In extreme cases, the test strip could "slip" from its fully inserted position. Investigation has shown that the issue occurs only as a triple-fault condition.

1. Older analyzers that are still in use in the filed, may have additional leeway within the strip guides, due to extensive use. This is a normal part of aging.
2. Strip carriers (bases that are used in test strip assembly) that trend to the lower end of the specification for thickness (but are still within specification), and
3. The analyzer is not kept on a flat, stable surface during testing, or is physically moved during testing.

Affected products