ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the ACCU-CHEK Inform II System to quanti
FDA device recall Z-1113-2013 · posted 2013-04-15 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Reason for recall
- 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.
- Action taken
- 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 day, seven days a week at 1-800-440-3638 for Accu check questions and 1-800-428-4674 for CoaguChek questions about the information contained in this UMDC.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- NBW
- Quantity affected
- Both devices 4467
- Distribution
- Nationwide Distribution.
- Date initiated
- 2013-03-06
- Date posted
- 2013-04-15
- Date terminated
- 2018-01-10
- Location
- Indianapolis, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM (K121679) | Roche Diagnostics | 2012-10-11 |