FDA Recall
Completed
PTS Panels CHOL+GLU Test Strips (REF 1765)
Recall: Z-1741-2022
·
Initiated August 16, 2022
Recall
- Recall Number
- Z-1741-2022
- Event Number
- 90791
- Firm
- Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
- FEI Number
- 3002698769
- Product Code
- CGA
- Status
- Completed
- Root Cause
- Labeling Change Control
- Initiated
- August 16, 2022
- Address
- 4600 Anson Blvd, Whitestown, IN, 46075-4489
Description
PTS Panels CHOL+GLU Test Strips (REF 1765)
Reason
Incorrect instructions for use were packaged into the final product.
Action
PTS Diagnostics notified customers on August 16, 2022, through an Urgent Medical Device Recall letter. Customers were instructed to return product for replacement. Distributors were asked to forward the notice to all customers/users who may have received the product. If you have any questions, please contact PTS Diagnostics' Customer Service directly, Monday through Friday, 8:00 AM to 5:00 PM, Eastern Time at +1 317-870-5610 or 877-570-8610 (U.S. toll-free).
Distribution
Worldwide distribution - US Nationwide distribution in the state of Virginia and the countries of Japan and Russia.