Recall Z-0741-2020 ยท NBW System, Test, Blood Glucose, Over The Counter
Polymer Technology Systems, Inc.
PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers
| Date | Mar 15, 2016 |
| Status | Terminated |
| Reason | This lot of test strips is showing an under-recovery when tested against a reference method. |
| Root cause | Storage |
| Action | Customer Notification Letters dated 3/15/16 was sent to customers. Distributors were instructed to do the following: We need your assistance to communicate this information to any customers to whom you have shipped this specific lot of product. As per Quality System Regulations, you must have full traceability of medical product to the end-user. Please advise your customers to complete the Customer Acknowledgement and Notification Form so that PTS Diagnostics can document that they have received the notification. Upon receipt of the acknowledgement, PTS Diagnostics will provide replacem |
| Quantity | 6467 |
| Distribution | The products were distributed to the following US states: CA, CT, FL, IN, MA, MD, MI, MN, NC, NJ, NM, NY, OR, PA, TN, and WI. The products were distributed to the following foreign countries: Australia, Belgium, Indonesia, Italy, Poland, South Africa, UK, and Vietnam. |
| FDA record | Open on fda.gov |