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
Affected Products
- CardioChek System - PTS Panels Cholesterol Test Strips
- 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.
- 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.
Affected products
A. CardioChek System - PTS Panels Cholesterol Test Strips
Lot or serial number
P832
Model or catalog number
1710
Companies
- Manufacturer
-
Polymer Technology Systems, Inc.
7736 Zionsville Rd
Indianapolis
46268
Indiana
UNITED STATES
B. CardioChek System - PTS Panels CHOL+HDL+GLU Test Strips
Lot or serial number
- I808
- I811
- I812
- I814
Model or catalog number
2412
Companies
- Manufacturer
-
Polymer Technology Systems, Inc.
7736 Zionsville Rd
Indianapolis
46268
Indiana
UNITED STATES