Pointe Scientific, Inc. Liquid 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Liquid 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.
Brand
Pointe Scientific, Inc.
Lot Codes / Batch Numbers
All lots containing the numbers 815701 in the lot number.
Products Sold
All lots containing the numbers 815701 in the lot number.
Pointe Scientific, Inc. is recalling Liquid HDL (PEG) Cholesterol Reagent, Pointe Scientific, Inc, Canton, MI; Catalog # 7-H7511-30, 8-H7 due to The firm initiated the recall due to the presence of visible contamination of the product.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The firm initiated the recall due to the presence of visible contamination of the product.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026