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U.S. Department of Health and Human Services

Class 2 Device Recall ACCUCHEK Inform

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  Class 2 Device Recall ACCUCHEK Inform see related information
Date Initiated by Firm June 30, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on October 03, 2005
Recall Number Z-1060-04
Recall Event ID 29388
510(K)Number K003846  K012210  
Product Classification System, Test, Blood Glucose, Over The Counter - Product Code NBW
Product ACCU-CHEK Inform meter; catalog No. 3035123.
Code Information All units.
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact
800-440-3638
Manufacturer Reason
for Recall		 Exposure to excessive disinfectant or cleaning solution may cause overheating, melting, or smoke.
FDA Determined
Cause 2		 Other
Action A recall notice dated 6/30/04 was sent to each customer instructing them on proper cleaning methods, asking them to inspect their units for damage, and providing warning stickers for attachment to the base units.
Distribution Nationwide.
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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