Roche Diagnostics Operations, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1616-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.
Product Description:

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.

Product Classification:

Class II

Date Initiated: April 14, 2014
Date Posted: May 21, 2014
Recall Number: Z-1616-2014
Event ID: 67961
Reason for Recall:

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.

Status: Terminated
Product Quantity: 590,136 boxes
Code Information:

5599423160, 5599415160, 5919967160, 5919959160, 5919983160, 5907675001

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated