Recall Z-1012-2010 ยท CGA Glucose Oxidase, Glucose
Polymer Technology Systems, Inc.
PTS Panels CHOL+HDL+GLU Panel test strips for professional use with CardioChek P-A analyzers, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.
| Date | Mar 5, 2010 (initiated Aug 4, 2009) |
| Status | Terminated |
| Reason | Possible under recovery of cholesterol, HDL and glucose. A loss of recoverable cholesterol and HDL cholesterol is a manageable to moderate health risk. The clinical applications analysis shows that lot 1891 shows such a loss of activity. A loss of recoverable Glucose measurement is a moderate to high risk, based upon the degree of under-recovery, and the frequency of occurrence. |
| Root cause | Other |
| Action | Consignees were notified by letter dated 7/28/09 to discontinue use of, and to destroy, the reagent and to contact the firm for replacement product. For questions, please contact the company Customer Service toll-free at 877-870-5610 or + 1-317-870-5610 (outside the US). |
| Quantity | 962 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071507 | PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS Polymer Technology Systems, Inc., Sep 10, 2007 |