Recall Z-0975-2010 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
Polymer Technology Systems, Inc.
PTS Panels CHOL+HDL Panel test strips for professional use with CardioChek P-A analyzer, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.Catalog # 1795. The product is used to measure total cholesterol, and HDL cholesterol, in whole blood.
| Date | Apr 2, 2010 (initiated Feb 20, 2009) |
| Status | Terminated |
| Reason | Extended expiration date; the product expired on February 12, 2009 but was labeled with a April 4, 2009 expiration date. |
| Root cause | Process control |
| Action | Consignees were notified by letter dated Febuary 20, 2009, advised of the problem, and that the firm would replace product not consumed by the true expiration date. Direct questions to Polymer Technology Systems, Inc. |
| Quantity | 3,748 vials |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071593 | PTS PANELS CHOL+HDL PANEL TEST STRIPS Polymer Technology Systems, Inc., Oct 15, 2007 |