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.
FDA Recall Z-1616-2014 · Posted 2014-05-13
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Recalling FirmRoche Diagnostics Operations, Inc.
Recall StatusTerminated
Product CodeNBW
Date Initiated2014-04-14
Date Terminated2014-09-18
Product Quantity590,136 boxes
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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