PTS Panels Lipids Panel test strips for self-testing or professional use with CardioChek P-A analyzers, Manufactured by
FDA device recall Z-1136-2010 · posted 2010-03-15 · Terminated
Recall details
- Recalling firm
- Polymer Technology Systems, Inc.
- Reason for recall
- Exhibits under-recovery of all analytes.
- Action taken
- Consignees were notified by letter dated 6/5/09, advised of the problem, and that the firm would replace product.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- CHH
- Quantity affected
- Not available.
- Distribution
- Nationwide and international.
- Date initiated
- 2009-06-05
- 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 LIPID PANEL TEST STRIPS (K023558) | Polymer Technology Systems, Inc. | 2002-11-15 |
| PTS PANELS LIPID PANEL TEST STRIPS (K022898) | Polymer Technology Systems, Inc. | 2002-09-24 |