Recall Z-1136-2010
Polymer Technology Systems, Inc. · initiated June 5, 2009
Product
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.
Codes / lots: Lot P814; exp. 9/2/09.
Reason for recall
Exhibits under-recovery of all analytes.
FDA-determined cause: Nonconforming Material/Component
Action taken
Consignees were notified by letter dated 6/5/09, advised of the problem, and that the firm would replace product.
Details
- Recall number
- Z-1136-2010
- Initiated
- June 5, 2009
- Posted by FDA
- March 15, 2010
- Terminated
- October 20, 2010
- Product code
- CHH – Enzymatic Esterase--Oxidase, Cholesterol
- Quantity
- Not available.
- Distribution
- Nationwide and international.
- Recalling firm
- Polymer Technology Systems, Inc., Indianapolis, IN