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U.S. Department of Health and Human Services

Class 2 Device Recall Pointe Scientific Glucose Hexokinase (Hitachi) Reagent HEX R2

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  Class 2 Device Recall Pointe Scientific Glucose Hexokinase (Hitachi) Reagent HEX R2 see related information
Date Initiated by Firm September 10, 2008
Date Posted October 31, 2008
Recall Status1 Terminated 3 on November 27, 2009
Recall Number Z-0220-2009
Recall Event ID 49466
510(K)Number K002199  
Product Classification Reagent Set - Product Code CFR
Product Pointe Scientific Liquid Glucose HEX (R2) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # HG420-R2. (Clinical chemistry)
Code Information Lots 727501-053 and 727501-070.
Recalling Firm/
Manufacturer		 Pointe Scientific, Inc.
5449 Research Dr
Canton MI 48188
For Additional Information Contact
734-487-8300
Manufacturer Reason
for Recall		 The inability of the product to maintain stated performance specifications through the stated shelf life.
FDA Determined
Cause 2		 Process control
Action Consignees are being notified by letter dated 9/10/08 which will be sent out via fax, email or certified mail to all direct account and drop-ship customers. Customers are advised to dispose of any recalled product found and to consider test results obtained with these lots questionable. Contact Pointe Scientific, Inc. at 1-800-757-5313 or 1-734-487-8300 for assistance.
Quantity in Commerce 4
Distribution Nationwide, Canada, China, Romania and Trinidad.
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 = CFR and Original Applicant = POINTE SCIENTIFIC, INC.
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