Z-1616-2014 Class II Terminated
FDA device recall Z-1616-2014 was initiated by Roche Diagnostics Operations, Inc. on Apr 14, 2014 and is designated Class II. 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… The recall status is terminated (terminated Sep 18, 2014). Affected quantity: 590,136 boxes.
Recall Details
- Product Type
- Devices
- Report Date
- May 21, 2014
- Initiation Date
- Apr 14, 2014
- Termination Date
- Sep 18, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 590,136 boxes
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.
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.
Distribution Pattern
Nationwide Distribution.
Code Information
5599423160, 5599415160, 5919967160, 5919959160, 5919983160, 5907675001
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1616-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026