PTS Panels CHOL+HDL Panel test strips for professional use with CardioChek P-A analyzer, Manufactured by Polymer Technol
FDA device recall Z-0975-2010 · posted 2010-04-02 · Terminated
Recall details
- Recalling firm
- Polymer Technology Systems, Inc.
- Reason for recall
- Extended expiration date; the product expired on February 12, 2009 but was labeled with a April 4, 2009 expiration date.
- Action taken
- Consignees were notified by letter dated Febuary 20, 2009, advised of the problem, and that the firm would replace product not consumed by the true expiration date. Direct questions to Polymer Technology Systems, Inc.
- Root cause
- Process control
- Status
- Terminated
- Product code
- CHH
- Quantity affected
- 3,748 vials
- Distribution
- Worldwide Distribution.
- Date initiated
- 2009-02-20
- Date posted
- 2010-04-02
- 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 CHOL+HDL PANEL TEST STRIPS (K071593) | Polymer Technology Systems, Inc. | 2007-10-15 |