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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 10, 2006
Date Posted February 28, 2006
Recall Status1 Terminated 3 on February 08, 2007
Recall Number Z-0568-06
Recall Event ID 34485
510(K)Number K982089  
Product Classification Glucose Dehydrogenase, Glucose - Product Code LFR
Product Accu-Chek Advantage II blood glucose test strips; Reference numbers 12030659001, 12030667001, 03137872001, 03137899001, 03000281001, 12030535001, 12030543001, 03033449001, 03033465001 and 12030543047 (All sold outside of the United States).
Code Information All lots.
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact
800-440-3638
Manufacturer Reason
for Recall		 There may be a thin piece of plastic across the mouth of the vial, preventing the cap from sitting snugly onto the vial and, if present, this situation will cause erroneously low or high blood glucose readings.
FDA Determined
Cause 2		 Other
Action Notifications (letters) dated 2/10/06 were sent to healthcare professionals, retail pharmacies, hospitals and mail order firms asking them to provide their customers with information instructing the users to inspect their strip vials and to not use strips from defective vials. Mail order accounts were instructed to forward the recall notification to end users.
Distribution Nationwide, Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Ecuador, England, France, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Mexico, New Zealand, Pakistan, Panama, Peru, Philippines, Poland, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan and Thailand.
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.
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