Recall Z-1136-2010 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
Polymer Technology Systems, Inc.
PTS Panels Lipids Panel test strips for self-testing or professional use with CardioChek P-A analyzers, Manufactured by Polymer Technology Systems, Inc. Catalog # 1710.
| Date | Mar 15, 2010 (initiated Jun 5, 2009) |
| Status | Terminated |
| Reason | Exhibits under-recovery of all analytes. |
| Root cause | Nonconforming Material/Component |
| Action | Consignees were notified by letter dated 6/5/09, advised of the problem, and that the firm would replace product. |
| Quantity | Not available. |
| Distribution | Nationwide and international. |
| FDA record | Open on fda.gov |