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U.S. Department of Health and Human Services

Class 2 Device Recall Roche ACCUCHEK Performa blood glucose meter

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  Class 2 Device Recall Roche ACCUCHEK Performa blood glucose meter see related information
Date Initiated by Firm June 10, 2009
Date Posted September 16, 2009
Recall Status1 Terminated 3 on October 29, 2010
Recall Number Z-2006-2009
Recall Event ID 52449
510(K)Number K070585  
Product Classification System, test, blood glucose - Product Code NBW
Product Roche ACCU-CHEK Performa blood glucose meters/kits, Roche Diagnostics, Indianapolis, IN.

Test strips for quantitative blood glucose measurements in fresh capillary, arterial, or neonatal blood, as well as in heparin (lithium or sodium) or EDTA anticoagulated venous blood.
Code Information All Lots with REF Numbers: 4861574019, 4861574020, 4861582014, 4861582019, 4861582020, 4861582034, 4862015023, 4862015027 and 4929381023.
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact
317-521-7252
Manufacturer Reason
for Recall		 There may be a significant negative bias when testing neonate samples.
FDA Determined
Cause 2		 Process control
Action Roche Diagnostics notified consignees in the affected countries of the problem by "Urgent Field Safety Notice" dated June 10, 2009 and instructed to cease using the Accu-Chek Performa and Accu-Chek Inform II systems on neonates, except for systems using test strips with advanced chemistry. For questions and additional information, contact your local Roche Diagnostics sales affiliate or sales representative.
Quantity in Commerce 1,518 of total products
Distribution International Distribution -- Argentina, Australia, Brazil, Chili, China, Colombia, Ecuador, France, Germany, Great Britain, Hong Kong, India, Korea, Malaysia, Mexico, New Zealand, Pakistan, Panama, Peru, Philippines, Singapore, South Africa, Taiwan, Thailand, Uruguay and Venezuela.
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 CORP.
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