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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 Device Recall ACCUCHEK Compact Plussee related information
Date Initiated by FirmApril 14, 2014
Date PostedMay 13, 2014
Recall Status1 Terminated 3 on September 18, 2014
Recall NumberZ-1616-2014
Recall Event ID 67961
510(K)NumberK113614 
Product Classification System, test, blood glucose, over the counter - Product Code NBW
ProductACCU-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
FEI Number 1823260
Recalling Firm/
Manufacturer		 Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information ContactAnne 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
ActionOn 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 Commerce590,136 boxes
DistributionNationwide Distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = NBW
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