Health Canada — Medical Devices · Canada · 2019-04-18 · Type III
As described by Health Canada — Medical Devices: CardioChek System - PTS Panels (Cholesterol Test Strips, CHOL+HDL+GLU Test Strips) (2019-03-26)
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Reported risk: 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. 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. 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 The analyzer is not kept on a flat, stable surface during testing, or is physically moved during testing.
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