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U.S. Department of Health and Human Services

Class 2 Device Recall Pointe Scientific Liquid Glucose HEX

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  Class 2 Device Recall Pointe Scientific Liquid Glucose HEX see related information
Date Initiated by Firm June 07, 2006
Date Posted August 03, 2006
Recall Status1 Terminated 3 on November 19, 2007
Recall Number Z-1332-06
Recall Event ID 35498
510(K)Number K002199  
Product Classification in vitro diagnostic - Product Code CFR
Product Glucose HEX R1 reagent sold by Pointe Scientific; in vitro diagnostic, Catalog nos 3-HG920-R1, 7-HG920-R1-67, 7-HG920-R1-600 and 7-HG920-R1-800.
Code Information Lots 431704, 511901 and 525101.
Recalling Firm/
Manufacturer		 Pointe Scientific, Inc.
5449 Research Dr
Canton MI 48188-2261
For Additional Information Contact
734-487-8300
Manufacturer Reason
for Recall		 Product does not meet performance specifications through its labeled expiration period.
FDA Determined
Cause 2		 Other
Action Customers were notified via recall letter dated 6/7/06 to cease using and to discard these lots, and to send back the recall response form for replacement stocks.
Quantity in Commerce 425 bottles
Distribution Worldwide, including USA, Canada, China, Panama, Russia 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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