Recall Z-1741-2022 ยท CGA Glucose Oxidase, Glucose
Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
PTS Panels CHOL+GLU Test Strips (REF 1765)
| Date | Aug 16, 2022 |
| Status | Completed |
| Reason | Incorrect instructions for use were packaged into the final product. |
| Root cause | Labeling Change Control |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162282 | CardioChek Plus Test System, CardioChek Home Test System Polymer Technology Systems, Inc. D/B/A Pts Diagnostics, Dec 22, 2016 |