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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 Recall
Roche ACCUCHEK Performa blood glucose meter
see related information
Date Posted September 16, 2009
Recall Status1 Terminated on October 29, 2010
Recall Number Z-2006-2009
Recall Event ID 52449
Premarket Notification
510(K) Number
K070585 
Product Classification System, Test, Blood Glucose, Over The Counter - 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, Indiana 46256-1025
Manufacturer Reason
for Recall
There may be a significant negative bias when testing neonate samples.
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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 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 CORP.
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