Date Initiated by Firm | September 10, 2008 |
Date Posted | October 31, 2008 |
Recall Status1 |
Terminated 3 on November 27, 2009 |
Recall Number | Z-0221-2009 |
Recall Event ID |
49466 |
510(K)Number | K002199 |
Product Classification |
Reagent Set - Product Code CFR
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Product | Pointe Scientific Liquid Glucose HEX Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # HG720-600 and HG920-756. (Clinical chemistry) |
Code Information |
HG720-600 lots 727501-303, 727501-355 and 727501-127. HG920-756 lot 727501-112. |
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 | 10 |
Distribution | Nationwide, Canada, China, Romania and Trinidad. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = CFR
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