ACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Meters; 17 count sample strip 51 count retail st
FDA device recall Z-1616-2014 · posted 2014-05-13 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Operations, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- NBW
- Quantity affected
- 590,136 boxes
- Distribution
- Nationwide Distribution.
- Date initiated
- 2014-04-14
- Date posted
- 2014-05-13
- Date terminated
- 2014-09-18
- Location
- Indianapolis, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM (K113614) | Roche Diagnostics | 2013-02-12 |