Recalls / —
—#126667
Product
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 product code
- NBW — System, Test, Blood Glucose, Over The Counter
- Device class
- Class 2
- Medical specialty
- Clinical Chemistry
- 510(k) numbers
- K113614
- Affected lot / code info
- 5599423160, 5599415160, 5919967160, 5919959160, 5919983160, 5907675001
Why it was recalled
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 (FDA determination)
Device Design
Action the firm took
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.
Recalling firm
- Firm
- Roche Diagnostics Operations, Inc.
- Address
- 9115 Hague Rd, Indianapolis, Indiana 46256-1025
Distribution
- Distribution pattern
- Nationwide Distribution.
Timeline
- Recall initiated
- 2014-04-14
- Posted by FDA
- 2014-05-13
- Terminated
- 2014-09-18
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #126667. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.