Device product
PTS Panels¿ CHOL+GLU Test Strips (REF 1765)
Z-1543-2018
Product summary
- Event
- Event 79778
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1543-2018
Official wording
Reason: Potential for loss of activity of the glucose analyte (under-recovery) prior to the full stated shelf life (August 2018)
Code information: Lot # A705 UDI (01)00381931765016(17)180813(10)A705
Distribution pattern: OH, PR, VA, CAL, IL, FL, WA, TN, KY, OH, MN, NY and Belgium, Hong Kong, Sweden, Australia, Russia, Sweden, Brazil, England
Derived failure modes
-
Unknown
Potential for loss of activity of the glucose analyte (under-recovery) prior to the full stated shelf life (August 2018)