Recall Z-1113-2013 ยท NBW System, Test, Blood Glucose, Over The Counter
Roche Diagnostics Operations, Inc.
ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the ACCU-CHEK Inform II System to quantitatively measure glucose (sugar).
| Date | Apr 15, 2013 (initiated Mar 6, 2013) |
| Status | Terminated |
| Reason | Roche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode reading meters had the potential of intermittent erroneous decoding of patient identification if barcodes being read fail to meet size and/or quality standards. |
| Root cause | Device Design |
| Action | Consignees of both devices were notified by Urgent Medical Device Correction letters sent via UPS Ground (receipt required) beginning 3/06/2013. The notice contained recommendation not to use EAN-13 barcode system and ensure barcodes used meet quality standards; use operator and patient lists (downloaded from a data manager) in order to check any decoded identification against the respective list. The notice directed forwarding of the notice if the product was further distributed. Customers were asked to complete the attached fax form. Contact the Customer Care Service Center, 24 hours a da |
| Quantity | Both devices 4467 |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121679 | ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM Roche Diagnostics, Oct 11, 2012 |