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U.S. Department of Health and Human Services

Class 2 Device Recall AUTOHDL CHOLESTEROL REAGENT SET

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  Class 2 Device Recall AUTOHDL CHOLESTEROL REAGENT SET see related information
Date Initiated by Firm January 29, 2009
Date Posted April 27, 2009
Recall Status1 Terminated 3 on October 20, 2010
Recall Number Z-1201-2009
Recall Event ID 51044
510(K)Number K992002  
Product Classification Ldl & Vldl precipitation, Hdl - Product Code LBR
Product Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Pointe Scientific, Inc., Canton, MI, Catalog Numbers: 10-H7545-80, 12-H7545-162, 3-H7545-L, 7-H7545-1000, 7-H7545-320, 7-H7545-40, 7-H7545-80, H7545-1000, H7545-320, H7545-40, H7545-80, HH945-240 and HH945-480.

The product is used for In vitro diagnostic for the quantitative determination of high-density lipoprotein cholesterol in human serum or plasma.
Code Information Lot Number: 818202, exp. 12/09.
Recalling Firm/
Manufacturer		 Pointe Scientific, Inc.
5449 Research Dr
Canton MI 48188
For Additional Information Contact
800-445-9853
Manufacturer Reason
for Recall		 The R1 reagent has microbial contamination.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Consignees were notified by "Urgent: Medical Device Recall" letter dated January 29, 2009, to conduct the recall to the retail level, to examine inventory and dispose of affected stocks on hand, and to complete the "Recall Return Response Form". Consignees were instructed to return their completed forms via mail, fax (1-734-483-1592) or e-mail to Pointe Scientific, Inc. (PS). Direct questions about the recall to PS Technical Support Department at 1-800-757-5313 or 1-734-487-8300.
Quantity in Commerce 717 kits, 164L
Distribution Worldwide Distribution -- US, Chile, Dominican Republic, Egypt, Ghana, Greece, India, Israel, Italy, Jamaica-West Indies, Korea, Malaysia, Mexico, Philippines, Poland, Romania, Serbia, Trinidad-West Indies, Turkey and Venezuela.
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 = LBR and Original Applicant = POINTE SCIENTIFIC, INC.
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