PTS Panels Cholesterol test strips for self-testing or professional use with CardioChek analyzers, Manufactured by Polym
FDA device recall Z-0871-2010 · posted 2010-03-01 · Terminated
Recall details
- Recalling firm
- Polymer Technology Systems, Inc.
- Reason for recall
- The memory chip was coded with incorrect product information.
- Action taken
- Polymer Technology Systems, Inc. issued an "Urgent - Field Correction" letter dated April 2, 2009. Consignees were advised of the problem and asked to identify how many kits were in inventory so that the firm could replace product. For further information, contact Polymer Technology Systems, Inc. Customer Service at 1-877-870-5610.
- Root cause
- Process control
- Status
- Terminated
- Product code
- CHH
- Quantity affected
- 486 vials
- Distribution
- Nationwide Distribution
- Date initiated
- 2009-04-02
- Date posted
- 2010-03-01
- 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 |
|---|---|---|
| MTM BIOSCANNER C TEST STRIPS (K990688) | Polymer Technology Systems, Inc. | 1999-06-24 |
| MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220 (K981493) | Polymer Technology Systems, Inc. | 1998-07-22 |