PTS Panels CHOL+HDL+GLU Panel test strips for professional use with CardioChek P-A analyzers, Manufactured by Polymer Te
FDA device recall Z-1012-2010 · posted 2010-03-05 · Terminated
Recall details
- Recalling firm
- Polymer Technology Systems, Inc.
- Reason for recall
- 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.
- Action taken
- 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).
- Root cause
- Other
- Status
- Terminated
- Product code
- CGA
- Quantity affected
- 962
- Distribution
- Nationwide.
- Date initiated
- 2009-08-04
- Date posted
- 2010-03-05
- Date terminated
- 2010-10-20
- Location
- Indianapolis, IN
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Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS (K071507) | Polymer Technology Systems, Inc. | 2007-09-10 |