Recall Z-1132-2010
Polymer Technology Systems, Inc. · initiated May 29, 2008
Product
PTS Panels LDL Cholesterol test strips for professional use with CardioChek P-A test systems, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN; Catalog No. 1753. For the quantitative measurement of LDL cholesterol in whole blood.
Codes / lots: Lots L771, exp. 12/04/08 and L781, exp. 12/17/2008.
Reason for recall
The expiration date was extended by 20 weeks without justification.
FDA-determined cause: Process change control
Action taken
An "URGENT-FIELD CORRECTION" letter dated May 29, 2008, was sent to customers. The letter described the product, problem and action to be taken by the customers. The customers are to please immediately identify the number of remaining LDL kits they currently have remaining in inventory of the specified lots and indicate the amount on the included Customer Acknowledgement and Confirmation letter and return via fax to 217-870-5608. The firm will ship a new lot of the LDL Cholesterol strips with new expiration dates to the customers. The customers are to please save the updated information and make the appropriate changes to their records. If you have any questions, please contact Customer Service at 317-870-5610 or toll-free at 877-870-5610.
Details
- Recall number
- Z-1132-2010
- Initiated
- May 29, 2008
- Posted by FDA
- March 15, 2010
- Terminated
- October 20, 2010
- Product code
- MRR – System, Test, Low Density, Lipoprotein
- Quantity
- not available.
- Distribution
- Worldwide distribution
- Recalling firm
- Polymer Technology Systems, Inc., Indianapolis, IN