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U.S. Department of Health and Human Services

Class 2 Device Recall Pointe Scientific Glucose Oxidase Reagent

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 Class 2 Device Recall Pointe Scientific Glucose Oxidase Reagentsee related information
Date Initiated by FirmNovember 03, 2008
Date PostedMarch 12, 2009
Recall Status1 Terminated 3 on December 03, 2009
Recall NumberZ-1091-2009
Recall Event ID 50131
510(K)NumberK810674 
Product Classification Glucose Oxidase - Product Code CGA
ProductGlucose Oxidase Reagent as follows: Pointe Scientific Glucose Oxidase Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # G7519-1L, G7519-500 and G7519-SAM. 2MM Diagnostics Glucose Oxidase Reagent Set, 2MM Corporation, Miami, FL; Reorder # RT-160-500. Pointe Scientific Glucose Oxidase Reagent, Pointe Scientific, Inc., Canton, MI; Catalog, MI; Catalog # 2-G7519-L, 7-G7519-100, 7-G7519-200, 7-G7519-1000, 8-G7519-100, and 12-RT-160-500. For the quantitative determination of Glucose in human serum. For in vitro diagnostic use only.
Code Information All lots beginning in 722601, Exp. 08/09. (Lots 722601, 722601-009, 722601-017, 722601-035, 722601-057, 722601-072, 722601-081, 722601-084, 722601-085, 722601-092, 722601-093, 722601-094, 722601-134, 722601-136, 722601-168, 722601-185, 722601-232, 722601-233, 722601-254, 722601-255, 722601-318, 722601-337, and 722601-361.)
FEI Number 1827821
Recalling Firm/
Manufacturer		 Pointe Scientific, Inc.
5449 Research Dr
Canton MI 48188
For Additional Information Contact
800-445-9853 Ext. 114
Manufacturer Reason
for Recall		The product is unable to maintain the specification for linearity through the shelf life of the product.
FDA Determined
Cause 2		Process control
ActionConsignees were notified via an Urgent: Medical Device Recall letter dated 11/3/08 that all test results obtained with these lots are questionable and that attending physicians should be informed to determine whether additional testing is required. Also, consignees should examine their inventories for any of the lot numbers listed and dispose of them. If the product has been further distributed, identify customers and notify them of the product recall by including a copy of the recall letter. The Recall Return Response Form should be completed and returned and upon receipt Pointe Scientific will replace any disposed of reagent. Questions should be directed to the Technical Support Department at 1-800-757-5313.
Quantity in Commerce1500 liters
DistributionWorldwide Distribution -- USA, Hong Kong, Indonesia, Israel, Jordan, Mexico, Nigeria, Poland, Russia, Serbia, Sri Lanka, Trinidad, and Venezuela.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = CGA
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