Z-0860-2010

Liquid HDL (PEG) Cholesterol Reagent, Pointe Scientific, Inc, Canton, MI; Catalog # 7-H7511-30, 8-H7511-30...

Name: Z-0860-2010 Liquid HDL (PEG) Cholesterol Reagent, Pointe Scientific, Inc, Canton, MI; Catalog # 7-H7511-30, 8-H7511-30...
Creator: Pointe Scientific, Inc.
Published: 2009-11-10
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2009-11-10 / Terminated / root cause: manufacturing process

FDA source

Pointe Scientific, Inc. began a recall of 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... on 2009-11-10. The reason FDA records is "The firm initiated the recall due to the presence of visible contamination of the product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0860-2010
Status: Terminated
Initiated: 2009-11-10
Posted: 2010-02-25
Terminated: 2011-02-11
Recalling firm: Horiba Instruments Incorporated
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.
Product code: LBR Ldl & Vldl Precipitation, Hdl
Reason for recall: The firm initiated the recall due to the presence of visible contamination of the product.
Root cause tag: manufacturing process
FDA root cause: 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: 237 sets plus 9L
Distribution: Worldwide Distribution -- USA, Bolivia, Ghana, Jamaica, Kenya, Korea, Malaysia, Mexico, Nicaragua, Nigeria, Philippines, Poland, Sri Lanka and Trinidad.
Product codes and lots: All lots containing the numbers 815701 in the lot number.

Product code LBR

K812574Class IHdl Cholesterol ReagentPointe Scientific, Inc., / cleared 1981-09-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)