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.
This recall has been terminated (originally issued February 25, 2010).
- Company
- Pointe Scientific, Inc.
- Recall Initiated
- November 10, 2009
- Posted
- February 25, 2010
- Terminated
- February 11, 2011
- Recall Number
- Z-0859-2010
- Quantity
- 379 sets
- Firm Location
- Canton, MI
- Official Source
- View on FDA website ↗
Reason for Recall
The firm initiated the recall due to the presence of visible contamination of the product.
Distribution
Worldwide Distribution -- USA, Bolivia, Ghana, Jamaica, Kenya, Korea, Malaysia, Mexico, Nicaragua, Nigeria, Philippines, Poland, Sri Lanka and Trinidad.
Lot / Code Info
All lots containing the numbers 815701 in the lot number.
Root Cause
Process control
Action Taken
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.