Recall Z-0975-2010
Polymer Technology Systems, Inc. · initiated February 20, 2009
Product
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.
Codes / lots: Lot G751.
Reason for recall
Extended expiration date; the product expired on February 12, 2009 but was labeled with a April 4, 2009 expiration date.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-0975-2010
- Initiated
- February 20, 2009
- Posted by FDA
- April 2, 2010
- Terminated
- October 20, 2010
- Product code
- CHH – Enzymatic Esterase--Oxidase, Cholesterol
- Quantity
- 3,748 vials
- Distribution
- Worldwide Distribution.
- Recalling firm
- Polymer Technology Systems, Inc., Indianapolis, IN