Recall Z-1132-2010 ยท MRR System, Test, Low Density, Lipoprotein
Polymer Technology Systems, Inc.
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.
| Date | Mar 15, 2010 (initiated May 29, 2008) |
| Status | Terminated |
| Reason | The expiration date was extended by 20 weeks without justification. |
| Root cause | Process change control |
| Action | 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 |
| Quantity | not available. |
| Distribution | Worldwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040693 | PTS PANELS LDL CHOLESTEROL TEST STRIPS Polymer Technology Systems, Inc., Jul 6, 2004 |