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U.S. Department of Health and Human Services

Class 2 Device Recall Liquid HDL (PEG) Cholesterol Reagent

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 Class 2 Device Recall Liquid HDL (PEG) Cholesterol Reagentsee related information
Date Initiated by FirmNovember 10, 2009
Date PostedFebruary 25, 2010
Recall Status1 Terminated 3 on February 11, 2011
Recall NumberZ-0860-2010
Recall Event ID 53810
510(K)NumberK812574 
Product Classification HDL, LDL, & VLDL Precipitation - Product Code LBR
ProductLiquid HDL (PEG) Cholesterol Reagent, Pointe Scientific, Inc, Canton, MI; Catalog # 7-H7511-30, 8-H7511-30, 3-H-7511-L. (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.
FEI Number 1827821
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
ActionConsignees 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 Commerce237 sets plus 9L
DistributionWorldwide Distribution -- USA, Bolivia, Ghana, Jamaica, Kenya, Korea, Malaysia, Mexico, Nicaragua, Nigeria, Philippines, Poland, Sri Lanka and Trinidad.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LBR
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