Device product
ACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Meters; 17 count sample strip 51 count retail strip; 102 count retail strip; 51 count MedBen strip 51 count Mail Order strip; Sample Kit 16 per case. The ACCU-CHEK Compact Plus Test Strips are for use with the ACCU-CHEK Compact Plus Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm.
Z-1616-2014
Product summary
- Event
- Event 67961
- Status
- Terminated
- Classification
- Class II
- Quantity
- 590,136 boxes
- Official record key
device-enforcement:Z-1616-2014
Official wording
Reason: Roche Diabetes Care has become aware the ACCU-CHEK Compact Plus test strips may produce erroneously low blood glucose readings in patients undergoing Ceftriaxone therapy. The interference is not described in the product labeling.
Code information: 5599423160, 5599415160, 5919967160, 5919959160, 5919983160, 5907675001
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
Roche Diabetes Care has become aware the ACCU-CHEK Compact Plus test strips may produce erroneously low blood glucose readings in patients undergoing Ceftriaxone therapy. The interference is not described in the product labeling.