Recall Z-1543-2018
Polymer Technology Systems, Inc. · initiated March 14, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
PTS Panels CHOL+GLU Test Strips (REF 1765)
Codes / lots: Lot # A705 UDI (01)00381931765016(17)180813(10)A705
Reason for recall
Potential for loss of activity of the glucose analyte (under-recovery) prior to the full stated shelf life (August 2018)
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-1543-2018
- Initiated
- March 14, 2018
- Terminated
- September 13, 2018
- Product code
- NBW – System, Test, Blood Glucose, Over The Counter
- Distribution
- OH, PR, VA, CAL, IL, FL, WA, TN, KY, OH, MN, NY and Belgium, Hong Kong, Sweden, Australia, Russia, Sweden, Brazil, England
- Recalling firm
- Polymer Technology Systems, Inc., Indianapolis, IN