Recall Z-1543-2018 ยท NBW System, Test, Blood Glucose, Over The Counter
Polymer Technology Systems, Inc.
PTS Panels CHOL+GLU Test Strips (REF 1765)
| Date | Mar 14, 2018 |
| Status | Terminated |
| Reason | Potential for loss of activity of the glucose analyte (under-recovery) prior to the full stated shelf life (August 2018) |
| Root cause | Under Investigation by firm |
| Action | Letters will be sent to each ship-to address, as well as each bill-to address via UPS with signature requirement. Customers will be instructed to immediately quarantine and destroy any materials remaining from these two lots. |
| Distribution | OH, PR, VA, CAL, IL, FL, WA, TN, KY, OH, MN, NY and Belgium, Hong Kong, Sweden, Australia, Russia, Sweden, Brazil, England |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041750 | PTS PANELS CHOL+GLU TEST PANEL Polymer Technology Systems, Inc., Jul 23, 2004 |