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U.S. Department of Health and Human Services

Class 1 Device Recall Pointe Scientific Liquid Glucose (HEXO) Reagent Set

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 Class 1 Recall
Pointe Scientific Liquid Glucose (HEXO) Reagent Set
see related information
Date Posted November 04, 2009
Recall Status1 Terminated on September 27, 2010
Recall Number Z-0104-2010
Recall Event ID 53583
Premarket Notification
510(K) Number
K971754 
Product Classification Hexokinase, Glucose - Product Code CFR
Product Pointe Scientific Liquid Glucose (HEXO) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s G7517-120,G7517-120, G7517-500, and G7517-1L; 8-G7517-120, 8-G7517-500, 3-G7517-L, 7-G7517-500 and 7-G7517-1000. (Clinical chemistry) Pointe Scientific Liquid Glucose (HEXO) is used for the quantitative determination of glucose in serum.
Code Information All lots beginning with the numbers 814301, 820502, 823901, 826801, 829401, 814301, 820502, and 831502.
Recalling Firm/
Manufacturer
Pointe Scientific, Inc.
5449 Research Dr
Canton, Michigan 48188
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
There is a loss of linearity. The product fails to maintain linearity specification of 500 mg/dL.
FDA Determined
Cause 2
DESIGN: Process Design
Action The firm issued a press release, and an amended press release, on 10/30/09. Consignees were notified by an Urgent: Medical Device Recall letter dated 10/19/09, which identified the problem; and, instructed testing laboratories to inform patients' attending physicians, and determine, with their input, whether confirmation of the previous test results will be required. Customers are to examine their inventory for any of the lot numbers listed on the letter; and, for any product that has been further distributed, those customers need to be identified and notified of this product recall by including a copy of the recall letter. Customers are to complete and return the Recall Return Response form and upon receipt, Pointe Scientific will replace any disposed of reagent. The recall was expanded to include two additional lots by letter dated 11/2/09.
Quantity in Commerce 400 kits plus 59 liters and 15 vials.
Distribution Worldwide Distribution -- USA, Israel, Mexico, South Africa, and West Indies.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CFR and Original Applicant = POINTE SCIENTIFIC, INC.
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