Recall Z-1616-2014 ยท NBW System, Test, Blood Glucose, Over The Counter
Roche Diagnostics Operations, Inc.
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 s
| Date | May 13, 2014 (initiated Apr 14, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | On 4/14/14, Roche Diagnostics Operations issued URGENT MEDICAL DEVICE CORRECTION notification to consignees which included description of the affected product and issue, clinical significance, and actions required. Consignees are directed to call the ACCU-CHEK Customer Care Service Center at 1-800-858-8072 for any questions about the information contained in the notification. |
| Quantity | 590,136 boxes |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113614 | ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM Roche Diagnostics, Feb 12, 2013 |