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
|
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
|
|
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.
|