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U.S. Department of Health and Human Services

Class 2 Device Recall ACCUCHEK Compact Plus

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 Class 2 Recall
ACCUCHEK Compact Plus
see related information
Date Posted May 13, 2014
Recall Status1 Open
Recall Number Z-1616-2014
Recall Event ID 67961
Premarket Notification
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, Indiana 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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NBW and Original Applicant = Roche Diagnostics
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