FDA Recall
Terminated
PTS Panels Cholesterol test strips for self-testing or professional use with CardioChek analyzers, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.Catalog # 1711. Intended to provide a quantitative measurement of total cholesterol in whole blood.
Recall: Z-0871-2010
·
Initiated April 2, 2009
Recall
- Recall Number
- Z-0871-2010
- Event Number
- 53768
- Firm
- Polymer Technology Systems, Inc.
- FEI Number
- 3015525148
- Product Code
- CHH
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- April 2, 2009
- Posted
- March 1, 2010
- Terminated
- October 20, 2010
- Address
- 7736 Zionsville Rd, Indianapolis, IN, 46268-2175
Description
PTS Panels Cholesterol test strips for self-testing or professional use with CardioChek analyzers, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.Catalog # 1711. Intended to provide a quantitative measurement of total cholesterol in whole blood.
Reason
The memory chip was coded with incorrect product information.
Action
Polymer Technology Systems, Inc. issued an "Urgent - Field Correction" letter dated April 2, 2009. Consignees were advised of the problem and asked to identify how many kits were in inventory so that the firm could replace product. For further information, contact Polymer Technology Systems, Inc. Customer Service at 1-877-870-5610.
Distribution
Nationwide Distribution
Quantity
486 vials