Date Initiated by Firm |
April 14, 2014 |
Date Posted |
May 13, 2014 |
Recall Status1 |
Terminated 3 on September 18, 2014 |
Recall Number |
Z-1616-2014 |
Recall Event ID |
67961 |
510(K)Number |
K113614
|
Product Classification |
System, test, blood glucose, over the counter - Product Code NBW
|
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.
|
Code Information |
5599423160, 5599415160, 5919967160, 5919959160, 5919983160, 5907675001 |
Recalling Firm/ Manufacturer |
Roche Diagnostics Operations, Inc. 9115 Hague Rd Indianapolis IN 46256-1025
|
For Additional Information Contact |
Anne Gill 317-576-2000 Ext. 249
|
Manufacturer 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.
|
FDA Determined Cause 2 |
Device Design |
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. |
Quantity in Commerce |
590,136 boxes |
Distribution |
Nationwide Distribution. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = NBW and Original Applicant = Roche Diagnostics
|