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U.S. Department of Health and Human Services

Class 2 Device Recall AccuChek

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  Class 2 Device Recall AccuChek see related information
Date Initiated by Firm February 12, 2003
Date Posted April 09, 2003
Recall Status1 Terminated 3 on September 15, 2003
Recall Number Z-0715-03
Recall Event ID 25542
510(K)Number K982002  K010362  
Product Classification Glucose Dehydrogenase, Glucose - Product Code LFR
Product Accu-Chek Comfort Curve glucose test strips; part numbers 2030420, 2030365, 2030373, 2030381, 3000133 and 3000141.
Code Information All lots.
Recalling Firm/
Manufacturer
Roche Diagnostics Corp.
9115 Hague Road
Indianapolis IN 46250-0457
For Additional Information Contact
800-858-8072
Manufacturer Reason
for Recall
Crack in the bottom of the test strip vial will cause erroneously low or high blood glucose readings.
FDA Determined
Cause 2
Other
Action Urgent Product Correction letters dated 2/12/03 were issued to pharmacists, specific health care providers, and the laboratory manager at customer accounts. Letter recipients were asked to advise their patients to inspect their vial for a crack prior to each use.
Distribution United States, Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Guatemala, Honduras, Hong Kong, Indonesia, Japan, Malaysia, Mexico, New Zealand, Norway, Pakistan, Peru, Philippines, Portugal, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, United Kingdom and Vietnam.
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 = LFR and Original Applicant = BOEHRINGER MANNHEIM CORP.
510(K)s with Product Code = LFR and Original Applicant = ROCHE DIAGNOSTICS CORP.
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