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U.S. Department of Health and Human Services

Class 2 Device Recall Liquid HDL (PEG) Cholesterol Reagent Set

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  Class 2 Device Recall Liquid HDL (PEG) Cholesterol Reagent Set see related information
Date Initiated by Firm November 10, 2009
Date Posted February 25, 2010
Recall Status1 Terminated 3 on February 11, 2011
Recall Number Z-0859-2010
Recall Event ID 53810
510(K)Number K812574  
Product Classification HDL, LDL, & VLDL Precipitation - Product Code LBR
Product Liquid HDL (PEG) Cholesterol Reagent Set. Pointe Scientific HDL Cholesterol Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # H7511-60 and Catalog # H7511-SAM. HDL Cholesterol Reagent Set, Pointe Scientific, Inc, Canton, MI; . (Clinical chemistry).

For the quantitative determination of high density lipoprotein (HDL) in cholesterol in serum.
Code Information All lots containing the numbers 815701 in the lot number.
Recalling Firm/
Manufacturer		 Pointe Scientific, Inc.
5449 Research Dr
Canton MI 48188
For Additional Information Contact
734-487-8300
Manufacturer Reason
for Recall		 The firm initiated the recall due to the presence of visible contamination of the product.
FDA Determined
Cause 2		 Process control
Action Consignees were notified by an Urgent: Medical Device Recall letter (sent by email, fax or through the mails) dated 11/10/09. The letter identified the affected product and instructed customers to immediately examine their inventory. If the product was further distributed their customers should be identified and notified of the recall. Customers are instructed to dispose of any product in stock. Questions should be directed to the Technical Support Department at 800-757-5313 or 734-487-8300.
Quantity in Commerce 379 sets
Distribution Worldwide Distribution -- USA, Bolivia, Ghana, Jamaica, Kenya, Korea, Malaysia, Mexico, Nicaragua, Nigeria, Philippines, Poland, Sri Lanka 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 = LBR and Original Applicant = POINTE SCIENTIFIC, INC.
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