PTS Panels LDL Cholesterol test strips for professional use with CardioChek P-A test systems, Manufactured by Polymer Te
FDA device recall Z-1132-2010 · posted 2010-03-15 · Terminated
Recall details
- Recalling firm
- Polymer Technology Systems, Inc.
- Reason for recall
- The expiration date was extended by 20 weeks without justification.
- 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.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- MRR
- Quantity affected
- not available.
- Distribution
- Worldwide distribution
- Date initiated
- 2008-05-29
- Date posted
- 2010-03-15
- Date terminated
- 2010-10-20
- Location
- Indianapolis, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PTS PANELS LDL CHOLESTEROL TEST STRIPS (K040693) | Polymer Technology Systems, Inc. | 2004-07-06 |