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U.S. Department of Health and Human Services

Class 2 Device Recall Pointe Scientific

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  Class 2 Device Recall Pointe Scientific see related information
Date Initiated by Firm June 12, 2006
Date Posted August 30, 2006
Recall Status1 Terminated 3 on November 19, 2007
Recall Number Z-1454-06
Recall Event ID 35497
510(K)Number K992002  
Product Classification Cholesterol Reagent Set - Product Code CCH
Product Liquid AutoHDL Cholesterol Reagent Set, Manufactured for Pointe Scientific, Inc.; Catalog Nos. HH945-240, HH945-480, H7545-40, H7545-80, H7545-320 and H7545-1000. A homogeneous method for the direct determination of high density lipoprotein (HDL) cholesterol in serum or plasma.
Code Information Lots 523002, exp. 2/07, and 531801, exp. 2/07.
Recalling Firm/
Manufacturer		 Pointe Scientific, Inc.
5449 Research Dr
Canton MI 48188-2261
For Additional Information Contact
734-487-8300
Manufacturer Reason
for Recall		 Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.
FDA Determined
Cause 2		 Other
Action Consignees were notified via recall letter dated 6/12/06 to cease using the product, conduct a recall to the user level, destroy product on hand and to notify the firm via the response form of the amount destroyed for replacement purposes. International accounts were notified via email.
Quantity in Commerce To be determined
Distribution Worldwide-USA and Greece, India, Korea, Lebanon, Pakistan, Poland, Singapore, Trinidad, Turkey, United Arab Emirates and Venezuela.
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 = CCH and Original Applicant = POINTE SCIENTIFIC, INC.
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